COMPOSITION AND METHOD FOR REDUCING ALLERGIC RESPONSE

Abstract

A method and kit for the sequential early introduction to an infant of at least nine allergens to decrease the infant's risk for developing allergies. The method and kit includes an initial lower exposure dose of a first allergen to be taken for a day or two, followed by a higher maintenance dose of the first allergen to be taken for a day or more. Additional allergens are added, each first at an initial lower dose for a day or more followed by a higher maintenance dose for a day or more. This patent continues until all nine allergens are being given to an infant at their maintenance doses. The allergens can be provided in powdered protein form in premeasured pouches for addition to baby formula/mother's milk. Alternatively, the allergens can be included in baby formula, or in other foods such as snack bars, cookies, or gels.

Claims

1. A kit for the introduction of premeasured doses of at least nine different allergens to an infant to decrease the infant's risk for developing allergies, the kit comprising: one or more first pre-dosed packages comprising a first allergen at an initial lower exposure dose; one or more second pre-dosed packages comprising the first allergen at a higher maintenance dose; one or more third pre-dosed packages comprising the first allergen at the maintenance dose and a second allergen at an initial lower exposure dose; and one or more fourth pre-dosed packages comprising the first allergen at the maintenance dose and the second allergen at a higher maintenance dose; one or more fifth pre-dosed packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, and a third allergen at an initial lower exposure dose; one or more sixth pre-dosed packages comprising the first allergen at the maintenance dose the second allergen at the maintenance dose, and the third allergen at a higher maintenance dose; one or more seventh pre-dosed packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; and a fourth allergen at an initial lower exposure dose; one or more eighth pre-dosed packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; and the fourth allergen at a higher maintenance dose; one or more nineth pre-dosed packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at a maintenance dose; and a fifth allergen at an initial lower exposure dose; one or more tenth pre-dosed packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; and the fifth allergen at a higher maintenance dose; one or more eleventh pre-dosed packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; the fifth allergen at the maintenance dose, and a sixth allergen at an initial lower exposure dose; one or more twelfth pre-dosed packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; the fifth allergen at the maintenance dose, and the sixth allergen at a higher maintenance dose; one or more thirteenth pre-dosed packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; the fifth allergen at the maintenance dose, the sixth allergen at the maintenance dose, and a seventh allergen at an initial lower exposure dose; one or more fourteenth pre-dosed packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; the fifth allergen at the maintenance dose, the sixth allergen at the maintenance dose, and the seventh allergen at a higher maintenance dose; one or more fifteenth pre-dosed packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; the fifth allergen at the maintenance dose, the sixth allergen at the maintenance dose, the seventh allergen at the maintenance dose; and an eighth allergen at an initial lower exposure dose; one or more sixteenth pre-dosed packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; the fifth allergen at the maintenance dose, the sixth allergen at the maintenance dose, the seventh allergen at the maintenance dose; and the eighth allergen at a higher maintenance dose; one or more seventeenth pre-dosed packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; the fifth allergen at the maintenance dose, the sixth allergen at the maintenance dose, the seventh allergen at the maintenance exposure dose; the eighth allergen at the maintenance dose; and a nineth allergen at an initial lower exposure dose; and one or more eighteenth pre-dosed packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; the fifth allergen at the maintenance dose, the sixth allergen at the maintenance dose, the seventh allergen at the maintenance dose; the eighth allergen at the maintenance dose; and the nineth allergen at a higher maintenance dose; wherein the first, second, third, fourth, fifth, sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth, sixteenth, seventeenth, and eighteenth pre-dosed packages are sequentially identified so that user will know the order of administration of the various packets; wherein the exposure doses of one or more of the allergens may optionally be gradually increased; and wherein the exposure doses of the first, second, third, fourth, fifth, sixth, seventh, eight, and ninth allergens are lower than the maintenance doses of the first, second, third, fourth, fifth, sixth, seventh, eight, and ninth allergens, respectively.

2. The kit of claim 1, wherein the first, second, third, fourth, fifth, sixth, seventh, eighth, and ninth allergens are each selected from the group consisting of cow's milk, chicken egg white, peanut, wheat, soy, sesame, fish, shellfish, and tree nuts.

3. The kit of claim 2, wherein the tree nuts are selected from the group consisting of almonds, Brazil nuts, cashews, chestnuts, filberts/hazelnuts, macadamia nuts, pecans, pistachios, pine nuts, shea nuts and walnuts.

4. The kit of claim 1, further comprising a container containing a mixture of the nine allergens each at a proper volumetric ratio to maintain a correct dose of each of the separate allergens at their respective higher maintenance doses when a given volume of the mixture of the nine allergens is administered to an infant.

5. The kit of claim 1, further comprising additional pre-dosed packages of at least one different additional allergen at an initial lower exposure dose and that same least one different additional allergen at a higher maintenance dose.

6. The kit of claim 1 wherein the first allergen comprises cow's milk, and the exposure dose of the first allergen ranges between 0.1-0.7 grams of cow's milk protein and the maintenance dose of the first allergen ranges between 0.3-1.5 grams of cow's milk protein, wherein the second allergen comprises cooked chicken egg white protein, and the exposure dose of the second allergen ranges between 0.01-0.1 grams of cooked chicken egg white protein and the maintenance dose of second allergen ranges between 0.05-0.5 grams of cooked chicken egg white protein, wherein the third allergen comprises peanut powder, and the exposure dose of the third allergen ranges between 0.05-0.3 grams of peanut protein and the maintenance dose of third allergen ranges between 0.1-0.9 grams of peanut protein, wherein the fourth allergen comprises wheat powder, and the exposure dose of the fourth allergen ranges between 0.05-0.5 grams of wheat powder and the maintenance dose of fourth allergen ranges between 0.2-1.0 grams of wheat powder, wherein the fifth allergen comprises soy protein, and the exposure dose of the fifth allergen ranges between 0.05-0.5 grams of soy protein and the maintenance dose of fourth allergen ranges between 0.2-1.0 grams of wheat powder, wherein the fifth allergen comprises soy powder, and the exposure dose of the fifth allergen ranges between 0.05-0.5 grams of soy powder and the maintenance dose of fifth allergen ranges between 0.2-1.0 grams of soy powder, wherein the sixth allergen comprises sesame powder, and the exposure dose of the fifth allergen ranges between 0.05-0.5 grams of soy powder and the maintenance dose of sixth allergen is about 0.2-1.0 grams of sesame powder, wherein the seventh allergen comprises walnut powder, and the exposure dose of the sixth allergen ranges between 0.05-0.5 grams of powder and the maintenance dose of seventh allergen ranges between 0.2-1.0 grams of walnut powder, wherein the eighth allergen comprises cashew powder, and the exposure dose of the eighth allergen ranges between 0.05-0.5 grams of cashew powder and the maintenance dose of eighth allergen ranges between 0.2-1.0 grams of cashew powder, and wherein the ninth allergen comprises almond powder, and the exposure dose of the ninth allergen ranges between 0.05-0.5 grams of almond powder and the maintenance dose of ninth allergen ranges between 0.2-1.0 grams of almond powder.

7. The kit of claim 6 wherein the order of administration of the first through ninth allergens may be shifted.

8. The kit of claim 1, wherein the allergens consist of particles having a particle size of less than about 200 microns.

9. A kit for the introduction to an infant of at least nine different allergens to decrease the infant's risk for developing allergies, the kit comprising: one or more first type of food packages comprising a quantity of food and a first allergen at an initial lower exposure dose; one or more second type of food packages comprising a quantity of food and the first allergen at a higher maintenance dose; one or more third type of food packages comprising a quantity of food, the first allergen at the maintenance dose, and a second allergen at an initial lower exposure dose; and one or more fourth type of food package comprising a quantity of food, the first allergen at the maintenance dose, and the second allergen at the maintenance dose; one or more fifth type of food packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, and a third allergen at an initial lower exposure dose; one or more sixth type of food packages comprising the first allergen at the maintenance dose the second allergen at the maintenance dose, and the third allergen at a higher maintenance dose; one or more seventh type of food packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; and a fourth allergen at an initial lower exposure dose; one or more eighth type of food packages comprising the first allergen at the maintenance dose the second allergen at the maintenance dose, the third allergen at the maintenance dose; and the fourth allergen at a higher maintenance dose; one or more nineth type of food packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at a maintenance dose; and a fifth allergen at an initial lower exposure dose; one or more tenth type of food packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; and the fifth allergen at a higher maintenance dose; one or more eleventh type of food packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; the fifth allergen at the maintenance dose, and a sixth allergen at an initial lower exposure dose; one or more twelfth type of food packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; the fifth allergen at the maintenance dose, and the sixth allergen at a higher maintenance dose; one or more thirteenth type of food packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; the fifth allergen at the maintenance dose, the sixth allergen at the maintenance dose, and a seventh allergen at an initial lower exposure dose; one or more fourteenth type of food packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; the fifth allergen at the maintenance dose, the sixth allergen at the maintenance dose, and the seventh allergen at a higher maintenance exposure dose; one or more fifteenth type of food packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; the fifth allergen at the maintenance dose, the sixth allergen at the maintenance dose, the seventh allergen at the maintenance exposure dose; and an eight allergen at an initial lower exposure dose; one or more sixteenth type of food packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; the fifth allergen at the maintenance dose, the sixth allergen at the maintenance dose, the seventh allergen at the maintenance exposure dose; and the eight allergen at a higher maintenance dose; one or more seventeenth type of food packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; the fifth allergen at the maintenance dose, the sixth allergen at the maintenance dose, the seventh allergen at the maintenance exposure dose; the eight allergen at the maintenance dose; and a nineth allergen at an initial higher exposure dose; and one or more eighteenth type of food packages comprising the first allergen at the maintenance dose, the second allergen at the maintenance dose, the third allergen at the maintenance dose; the fourth allergen at the maintenance dose; the fifth allergen at the maintenance dose, the sixth allergen at the maintenance dose, the seventh allergen at the maintenance exposure dose; the eight allergen at the maintenance dose; and the nineth allergen at a higher maintenance dose; wherein the first, second, third, fourth, fifth, sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth, sixteenth, seventeenth, and eighteenth food packages are identified so that user will know the order of administration of the various food packages; wherein the exposure doses of one or more of the allergens may optionally be gradually increased; and wherein the exposure dose of each separate allergen is lower than the maintenance dose of the same allergen.

10. The kit of claim 9, wherein the first, second, third, fourth, fifth, sixth, seventh, eighth, and ninth allergens are each selected from the group consisting of cow's milk, chicken egg white, peanut, wheat, soy, sesame, fish, shellfish, and tree nuts.

11. The kit of claim 10, wherein the tree nuts are selected from the group consisting of almonds, Brazil nuts, cashews, chestnuts, filberts/hazelnuts, macadamia nuts, pecans, pistachios, pine nuts, shea nuts and walnuts.

12. The kit of claim 9 wherein the first allergen comprises cow's milk, and the exposure dose of the first allergen ranges between 0.1-0.7 grams of cow's milk protein and the maintenance dose of the first allergen ranges between 0.3-1.5 grams of cow's milk protein, wherein the second allergen comprises cooked chicken egg white protein, and the exposure dose of the second allergen ranges between 0.01-0.1 grams of cooked chicken egg white protein and the maintenance dose of second allergen ranges between 0.05-0.5 grams of cooked chicken egg white protein, wherein the third allergen comprises peanut powder, and the exposure dose of the third allergen ranges between 0.05-0.3 grams of peanut protein and the maintenance dose of third allergen ranges between 0.1-0.9 grams of peanut protein, wherein the fourth allergen comprises wheat powder, and the exposure dose of the fourth allergen ranges between 0.05-0.5 grams of wheat powder and the maintenance dose of fourth allergen ranges between 0.2-1.0 grams of wheat powder, wherein the fifth allergen comprises soy protein, and the exposure dose of the fifth allergen ranges between 0.05-0.5 grams of soy protein and the maintenance dose of fourth allergen ranges between 0.2-1.0 grams of wheat powder, wherein the fifth allergen comprises soy powder, and the exposure dose of the fifth allergen ranges between 0.05-0.5 grams of soy powder and the maintenance dose of fifth allergen ranges between 0.2-1.0 grams of soy powder, wherein the sixth allergen comprises sesame powder, and the exposure dose of the fifth allergen ranges between 0.05-0.5 grams of soy powder and the maintenance dose of sixth allergen is about 0.2-1.0 grams of sesame powder, wherein the seventh allergen comprises walnut powder, and the exposure dose of the sixth allergen ranges between 0.05-0.5 grams of powder and the maintenance dose of seventh allergen ranges between 0.2-1.0 grams of walnut powder, wherein the eighth allergen comprises cashew powder, and the exposure dose of the eighth allergen ranges between 0.05-0.5 grams of cashew powder and the maintenance dose of eighth allergen ranges between 0.2-1.0 grams of cashew powder, and wherein the ninth allergen comprises almond powder, and the exposure dose of the ninth allergen ranges between 0.05-0.5 grams of almond powder and the maintenance dose of ninth allergen ranges between 0.2-1.0 grams of almond powder.

13. The kit of claim 9, further comprising a container containing a mixture of the nine allergens each at a proper volumetric ratio to maintain a correct dose of each of the nine separate allergens at their respective higher maintenance doses when a given volume of the mixture of the nine allergens is administered to an infant.

14. The kit of claim 9, further comprising additional food packages of at least one different additional allergen at an initial lower exposure dose and that same at least one different additional allergen at a higher maintenance dose.

15. The kit of claim 9, wherein the food packages comprise at least one of an infant formula, infant food in jars, pouches, snack bars, cookies, or a gel.

16. The kit of claim 9, wherein the allergens consist of particles having a particle size of less than about 200 microns.

17. A method for the introduction of premeasured doses of at least nine allergens to an infant to decrease the infant's risk for developing allergies, the method comprising the steps of: (a) administering to the infant a first allergen at a lower initial exposure dose for one or more days; (b) subsequently administering to the infant the first allergen at a higher maintenance dose for one or more days; (c) subsequently administering to the infant the first allergen at the maintenance dose and a second allergen at a lower initial exposure dose for one or more days; (d) subsequently administering the first allergen at the maintenance dose and the second allergen at a higher maintenance dose for one or more days; (e) subsequently administering the first and the second allergens at their maintenance doses, and a third allergen at a lower initial exposure dose for one or more days; (f) subsequently administering the first and the second allergens at their maintenance doses and the third allergen at a high maintenance dose for one or more days; (g) subsequently administering the first, second, and third allergens at their maintenance doses, and a fourth allergen at a lower initial exposure dose for one or more days; (h) subsequently administering the first, second, and third allergens at their maintenance doses, and the fourth allergen at a high maintenance dose for one or more days; (i) subsequently administering the first, second, third, and fourth allergens at their maintenance doses, and a fifth allergen at a lower initial exposure dose for one or more days; (j) subsequently administering the first, second, third, fourth allergens at their maintenance doses, and the fifth allergen at a high maintenance dose for one or more days; (k) subsequently administering the first, second, third, fourth, and fifth allergens at their maintenance doses, and a sixth allergen at a lower initial exposure dose for one or more days; (l) subsequently administering the first, second, third, fourth, and fifth allergens at their maintenance doses, and the sixth allergen at a high maintenance dose for one or more days; (m) subsequently administering the first, second, third, fourth, fifth, and sixth allergens at their maintenance doses, and a seventh allergen at a lower initial exposure dose for one or more days; (n) subsequently administering the first, second, third, fourth, fifth, and sixth allergens at their maintenance doses, and the seventh allergen at a high maintenance dose for one or more days; (o) subsequently administering the first, second, third, fourth, fifth, sixth, and seventh allergens at their maintenance doses, and an eighth allergen at a lower initial exposure dose for one or more days; (p) subsequently administering the first, second, third, fourth, fifth, sixth, and seventh allergens at their maintenance doses, and the eighth allergen at a high maintenance dose for one or more days; (q) subsequently administering the first, second, third, fourth, fifth, sixth, seventh, and eighth allergens at their maintenance doses, and a ninth allergen at a lower initial exposure dose for one or more days; and (r) subsequently administering the first, second, third, fourth, fifth, sixth, seventh, and eighth allergens at their maintenance doses, and the ninth allergen at a high maintenance dose for multiple days.

18. The method of claim 17 wherein the exposure doses may optionally be gradually increased.

19. The method of claim 17 wherein the nine allergens are administered to the infant at their maintenance doses for several months.

20. The method of claim 17 wherein the allergens are each selected from the group consisting of cow's milk, egg, peanut, wheat, soy, sesame, fish, shellfish, and tree nuts.

21. The method of claim 17 wherein the premeasured doses of allergens are mixed into the infant's breast milk, formula, or food and administered enterally.

22. The method of claim 17 wherein the premeasured doses are in the form of a) pre-dosed daily packets, packages, or pouches, b) measured powder supplements, c) gels, d) infant formula, or e) other foods.

23. The method of claim 17 wherein the premeasured doses are in the form of sequentially numbered packages so that users are guided when to administer each respective package.

24. The method of claim 17 wherein the first allergen comprises cow's milk, and the exposure dose of the first allergen ranges between 0.1-0.7 grams of cow's milk protein and the maintenance dose of the first allergen ranges between 0.3-1.5 grams of cow's milk protein, wherein the second allergen comprises cooked chicken egg white protein, and the exposure dose of the second allergen ranges between 0.01-0.1 grams of cooked chicken egg white protein and the maintenance dose of second allergen ranges between 0.05-0.5 grams of cooked chicken egg white protein, wherein the third allergen comprises peanut powder, and the exposure dose of the third allergen ranges between 0.05-0.3 grams of peanut protein and the maintenance dose of third allergen ranges between 0.1-0.9 grams of peanut protein, wherein the fourth allergen comprises wheat powder, and the exposure dose of the fourth allergen ranges between 0.05-0.5 grams of wheat powder and the maintenance dose of fourth allergen ranges between 0.2-1.0 grams of wheat powder, wherein the fifth allergen comprises soy protein, and the exposure dose of the fifth allergen ranges between 0.05-0.5 grams of soy protein and the maintenance dose of fourth allergen ranges between 0.2-1.0 grams of wheat powder, wherein the fifth allergen comprises soy powder, and the exposure dose of the fifth allergen ranges between 0.05-0.5 grams of soy powder and the maintenance dose of fifth allergen ranges between 0.2-1.0 grams of soy powder, wherein the sixth allergen comprises sesame powder, and the exposure dose of the fifth allergen ranges between 0.05-0.5 grams of soy powder and the maintenance dose of sixth allergen is about 0.2-1.0 grams of sesame powder, wherein the seventh allergen comprises walnut powder, and the exposure dose of the sixth allergen ranges between 0.05-0.5 grams of powder and the maintenance dose of seventh allergen ranges between 0.2-1.0 grams of walnut powder, wherein the eighth allergen comprises cashew powder, and the exposure dose of the eighth allergen ranges between 0.05-0.5 grams of cashew powder and the maintenance dose of eighth allergen ranges between 0.2-1.0 grams of cashew powder, and wherein the ninth allergen comprises almond powder, and the exposure dose of the ninth allergen ranges between 0.05-0.5 grams of almond powder and the maintenance dose of ninth allergen ranges between 0.2-1.0 grams of almond powder.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIG. 1 is a table showing the dosing regimen for an exemplary three-allergen early introduction kit of the invention.

[0020] FIG. 2 is a table showing the dosing regimen for an exemplary five-allergen early introduction kit of the invention.

[0021] FIG. 3 is a front view of three stick packs marked with day number for an exemplary formulation of the kit of invention.

[0022] FIG. 4 is a table showing the dosing regimen for an exemplary nine-allergen early introduction kit of the invention.

DETAILED DESCRIPTION

[0023] The invention is a ground-breaking solution to the difficulties that infant caretakers face with early food introduction for infants. It is a dietary supplement aimed at broad adoption and a substantial reduction of food allergies on a population level. This supplement, a powder that mixes easily with breast milk or formula or in infant foods, includes “culprit allergens” from the foods most commonly associated with childhood food allergy. Made from the powder of natural foods, the daily dose regimen has been formulated specifically to promote the development of tolerance via the gastrointestinal system. While it is impossible to prevent all reactions to food, our dosing regimen is specifically designed to ensure that reactions are mild and identified early, if they occur. In addition to the evidence-based dose escalation noted above, another innovative feature involves sequential introduction of food allergens.

[0024] Through easy-to-follow daily use with breastmilk or formula, starting at about four months of age, infants will be exposed to common food allergens during the key critical window of immune development. In one embodiment of the invention, the maintenance formulation includes three allergens, namely cow's milk, chicken egg white, and peanut, which together represent over 80% of all childhood food allergies. It is noted that while cow's milk is used, cow's milk yogurt or whey and casein powder can be used instead. Other kits can encompass additional proteins, addressing the vast majority of all causes of IgE-mediated food allergy. The dosing regimen is evidence-based, drawn from the methodology of recent randomized trials as well as published clinical experience with oral food challenges in allergists' offices. Parents and other caregivers can take comfort in a dosing regimen developed by allergists, specifically designed to reduce the risk of food allergy development and with safety as the constant priority.

[0025] What the invention is not, is the introduction of microdoses or homeopathic approaches. There is a widely described concern among allergists that introducing allergens at doses that are 1) too low and 2) too infrequent can in fact promote the sensitization pathway and therefore increase rather than reduce food allergy incidence. Furthermore, the method and kit of the invention is not an oral immunotherapy that stimulates or suppresses an infants' immune system to help his or her body fight off allergies. Rather, it is a treatment that helps the infant or child develop an immune system that does not overreacts upon exposure to allergens, and thus can help a child grow up without food allergies, or at least having fewer and less severe food allergies than might otherwise be the case. Through the innovative, gentle and gradual daily dosing regimen, the inventors have maximized the efficacy of the method and kit while adhering to strict safety considerations.

[0026] In a preferred embodiment, the multiple allergen early introduction system is a kit comprising daily dietary supplements and instructions for use. The system is a stepwise program of daily use, administered to infants via suspension of the supplement powder in breast milk, formula, or solid foods. The daily program incorporates increases in protein exposure, sequential introduction, and promotion of tolerance. First exposure formulations use protein amounts determined to be in a range of low provoking doses, as established in the medical literature. By utilizing low provoking doses, reactions if they do occur are significantly more likely to be mild in nature. In the event of any reaction, including but not limited to rashes or gastrointestinal upset, parents and other caregivers are able to present an exact description of exposure history to their pediatrician or allergist. This approach is truly ground-breaking in its ability to reduce the burden of confusing and inconsistent testing that children face when they experience any food reactions in current practice. Focused testing is proven to be the best approach to allergy diagnosis, and our dosing regimen allows families to do just that.

[0027] After it has been confirmed that the exposure dose of a particular protein is well tolerated, the infant will continue to be given packets of the allergen protein, which subsequent packets (or foods containing the allergens) will include a higher, “maintenance” dose of the now cleared protein. Thus, each day's supplement involves either 1) duplication of previous allergen amounts to promote tolerance and allow for detection of delayed reactions, 2) increase of previous allergen amount to achieve maintenance dosing levels, or 3) addition of a new food allergen for sequential introduction. Once an allergen has been introduced, it is included in all subsequent days of the guided program.

[0028] The “exposure” phase involves graded increases in allergen amount as well as sequential introduction of new allergens. Once maintenance levels of each have been attained, continuation at these levels is done through daily administration during the “maintenance” phase. An exemplary introduction kit having five different allergens can contain a 30-day supply consisting of daily supplements for both the exposure and maintenance phase. Busy caregivers, whether breastfeeding, pumping, formula feeding, or some combination of these three, will benefit from the ease of use of the kit and method. Moreover, absolutely no changes in feeding practices are needed for this program. The product's powder comes in easily portable packets and no extra supplies are needed.

[0029] Continuation kits contain the maintenance phase formulations only. The formulations and duration of the exposure phase depends on the number and type of allergens introduced. FIG. 1 is an exemplary dosing chart for a three-allergen introduction system. FIG. 1 is illustrative, but the guided system is not limited to a three-allergen system and the method described above applies to additional allergens as well.

[0030] The dosing chart includes initial dosing derived from “low provoking dose” data as well as protocols from food allergy prevention studies including LEAP, EAT, and PETIT.

[0031] The food allergen proteins are sourced from the powders of whole foods. These whole food powders are verified to be pure and limited to the specific whole food as well as produced via good manufacturing practices. For the referenced exemplary three-allergen example, the protein powders or flours consist of organic cow's milk, organic cooked chicken egg white, and organic peanut powder/flour.

[0032] FIG. 1 lists the representative protein components of a three-allergen early introduction system. The daily supplement can also include 400 IU of Vitamin D3, probiotics including but not limited to Streptococcus thermophilus and Lactobacillus delbrueckii ssp bulgaricus (both of which are used in the production of cow's milk yogurt) and Bifidobacterium infantis. The powders are preferably made by known techniques including freeze or spray drying, milling, sifting, vibratory sifting, and vacuum odor removal of the various products

[0033] In its most complete form, the kit of the invention is made up of the following components. Daily supplements are provided in the form of a powder contained within a specifically labeled package, such as a stick pack or sealed pouch. Hereinafter the inventor refers to the packaging as a stick pack but the format can be as desired. The stick pack specifies the day within the guided system, preferably both through verbiage and pictorially, e.g., DAY 1, DAY 2, . . . DAY 30. The stick packs themselves may preferably be arranged within a box with a designated sequence. The box contains written instructions printed on the packaging as well as an insert. Combined, these components make up the multiple allergen early introduction system kit.

[0034] The most complete form of performing the method associated with the disclosed device consists of the following steps: On a daily basis, and according to the instructions for use, the infant's caregiver is to tear open the indicated stick pack, empty its contents into either 1) an infant bottle containing breast-milk, 2) an infant bottle containing infant formula, or 3) a bowl of infant food. For options 1) and 2), the bottle is to be swirled gently until the powder is in suspension. For option 3), the content is stirred into the infant food. The bottle or infant food is then to be preferably given to the infant within five minutes. If there is a delay in administration or any settling is noticed, the bottle will again be swirled gently prior to feeding. The entire contents of each stick pack are to be consumed by the infant daily during the guided system. Empty stick packs are to be disposed.

[0035] The maintenance phase stick packs are to be continued daily until the infant is tolerating a wide range of solid foods ensuring diet diversity. Once the initial introduction kit has been completed, subsequent multiple allergen supplements will be available through 30-day maintenance kits.

[0036] Turning back to FIG. 1, it is a table that illustrates an exemplary dosing regimen for a three-allergen early introduction system, which is one particular version of the kit. According to this embodiment, the amount and type of protein is listed alongside the day of the guided program. Day 1 is the exposure dose of cow's milk protein. Day 2 repeats this dose for promotion of tolerance as well as for identification of delayed reactions. The inventor considers two days at the exposure dose to be long enough for the infant's caregiver to observe if there has been any delayed reaction, yet not unnecessarily prolonging the time to reach the maintenance dose. Day 3 increases this dose as part of the graded introduction method. Day 4 repeats Day 3′s dose for promotion of tolerance as well as for identification of delayed reactions. The exposure dose of the cow's milk powder protein will preferably be given for two days and will range between about 0.05 and 0.5 grams and will preferably be about 0.2 grams, with the exposure dose being increased after two days to the maintenance dose, which will range between about 0.2 and 1 grams and will preferably be about 0.57 grams. Day 5 includes the previous maintenance dose of cow's milk protein, with the addition of an exposure dose of cooked chicken egg white protein. Day 6 includes the previous maintenance dose of cow's milk protein, and repeats Day 5's dose of cooked chicken egg white protein for promotion of tolerance as well as for identification of delayed reactions. Days 7 and 8 include the previous maintenance dose of cow's milk protein with the addition of a maintenance dose of cooked chicken egg white protein. The exposure dose of the cooked chicken egg white powder protein will preferably be given for two days and will range between about 0.01 and 0.1 grams and will preferably be about 0.025 grams, with the exposure dose being increased after two days to the maintenance dose, which will range between about 0.05 and 0.5 grams and will preferably be about 0.125 grams. Days 9 and 10 include the previous maintenance doses of cow's milk protein and cooked chicken egg white protein, with the addition of an exposure dose of peanut protein which will range between about 0.05 and 0.3 grams and will preferably be about 0.1 grams. For days 11 and 12, the packets will include the previous maintenance doses of cow's milk protein and cooked chicken egg white protein, with the addition of a maintenance dose of peanut protein which will range between about 0.1 and 0.9 grams and will preferably be about 0.43 grams. Days 13-30 will follow the same pattern of graded and sequential introduction, until maintenance dosing of milk, egg, and peanut is achieved, and represents the maintenance phase of the system.

[0037] Although the chart in FIG. 1 shows first the introduction of cow's milk protein, then cooked chicken egg white protein, and lastly peanut protein, the relative order of the introduction of the cow's milk protein, cooked chicken egg white protein, and peanut protein may not be important and can thus be swapped around; such as first cooked chicken egg white protein, second peanut protein cow's, and third cow's milk protein, or first cooked chicken egg white protein, second peanut protein cow's, and third milk protein, or first peanut protein, second cow's milk protein, and last cooked chicken egg white protein, etc.

[0038] The staged dosing for the various packages described with reference to FIG. 1 are for cow's milk powder, chicken egg powder, and peanut powder/flour. In another embodiment of the invention, the kit and method comprises these three basic protein powders plus one or more additional powders containing different food allergens which can be introduced either after the initial cow's milk powder, chicken egg powder, and peanut powder, or even before and/or interspersed with dosing with the cow's milk powder, the chicken egg powder, and the peanut powder/flour. However, since cow's milk, chicken egg, and peanut allergies as a group constitute about 80% of the common food allergies of childhood, it makes sense to introduce these allergens first. Alternately, in a further embodiment of the invention, the kit and method comprises the administration of the additional powders which will be introduced after the infant has first consumed the starter kit with cow's milk powder, the chicken egg powder, and the peanut powder/flour.

[0039] Turning now to the additional powders, they can include tree nuts powder. Some common tree nuts that cause allergies include almonds, Brazil nuts, cashews, chestnuts, filberts/hazelnuts, macadamia nuts, pecans, pistachios, pine nuts, shea nuts and walnuts. Since some people are allergic to some but not all tree nuts, in practice the additional powder will include a blend of different powdered tree nuts, also sometimes referred to as tree nut flours. These additional powders can also include whitefish powder. Whitefish is a fisheries term for several species of demersal fish with fins, particularly Atlantic cod (Gadus morhua), Caspian kutum (Rutilus kutum), whiting (Merluccius bilinearis), and haddock (Melanogrammus aeglefinus), but also hake (Urophycis), pollock (Pollachius), or others. The whitefish powder is made from at least one of these dehydrated fish species. These additional powders can likewise include shellfish powder. Shellfish includes shelled mollusks such as abalone, clams, mussels, oysters, scallops and cockles, and crustaceans, such as crabs, shrimps, prawns, lobsters, and crawfish. Most allergies from shellfish are to crustaceans. The shellfish powder can constitute shellfish which is dehydrated and ground to a fine powder. Lastly, the additional powder can comprise wheat powder/flour, soy protein powder/flour, and/or sesame powder/flour. The doses selected for these additional protein powders will be determined based on data regarding provoking doses of each protein and the higher maintenance dose for each protein. These additional proteins will be introduced in the same staged manner with a first lower provoking dose for one and preferably two to three days, followed by the higher maintenance dose that will continue.

[0040] FIG. 2 is a chart showing a dosing schedule for an exemplary embodiment of a five allergen early introduction system kit, with the allergens being in cow's milk powder, chicken egg white powder, peanut powder/flour, wheat powder/flour, and soy powder/flour. As noted above, the relative order of administration of the cow's milk powder, chicken egg white powder, peanut powder, wheat powder, and soy powder can be shifted. In this exemplary embodiment, the dosing of the cow's milk powder, chicken egg powder, peanut powder can remain the same as in the three allergen early introduction system kit as in FIG. 1. The dosing of the wheat powder and soy powder will be as follows. The exposure dose of the wheat powder protein will preferably be given for two days (beginning on day 13) and will range between about 0.05 and 0.5 grams and will preferably be about 0.1 grams, with the exposure dose being increased after two days to the maintenance dose (beginning on day 15), which will range between about 0.2 and 1 grams and will preferably be about 0.4 grams. Packets of the product will continue to include the maintenance dose of the wheat powder. Next, the exposure dose of the soy powder protein will preferably be given for two days (beginning on day 17) and will range between about 0.05 and 0.5 grams and will preferably be about 0.1 grams, with the exposure dose being increased after two days (beginning on day 19) to the maintenance dose, which will range between about 0.2 and 1 grams and will preferably be about 0.4 grams. Once the maintenance dose is reached (day 19), all subsequent packets of the product will continue to include the maintenance doses of all the allergen containing powders.

[0041] FIG. 2 describes a kit with powders containing five allergens, viz., cow's milk, chicken egg white, peanut, wheat, and soy. Other kits are contemplated consisting of other noted food allergens. However, regardless of the kit, each allergen will be introduced in a first introductory, lower dose, which after at least one day, and preferably two days, will be increased to a higher maintenance dose. It is also possible that an intermediate dose be given, or that the maintenance dose can be increased gradually in additional steps.

[0042] Turning to FIG. 3, there is shown three stick packs for Day 1, Day 2, and Day 3 of an exemplary kit of the invention, which would preferably contain 30 such packs, each sequentially numbered, and containing the amount of allergen containing powder as noted in FIG. 1. Accordingly, the various stick packs will contain the various powders containing the allergen(s) in pre-dosed sticks packs, each bearing its unique number so that the infant's caregiver will know which package to mix in with breastmilk, formula, baby food, etc., on which day.

[0043] FIG. 4 is a chart showing a dosing schedule for an exemplary embodiment of a nine allergen early introduction system kit, with the allergens comprising cow's milk powder, chicken egg white powder, peanut powder/flour, wheat powder/flour, soy powder/flour, sesame powder/flour, walnut powder/flour, cashew powder/flour, and almond powder/flour. As noted above with respect to the embodiments with three and five protein powders, the relative order of administration of the cow's milk powder, chicken egg white powder, peanut powder, wheat powder, soy powder, sesame powder, walnut powder, cashew powder, and almond powder can be shifted.

[0044] According to this exemplary embodiment, the amount and type of protein is listed alongside the day of the guided program. Day 1 is the exposure dose of cow's milk protein. Day 2 repeats this dose for promotion of tolerance as well as for identification of delayed reactions. The inventor considers two days at the exposure dose to be long enough for the infant's caregiver to observe if there has been any delayed reaction, yet not unnecessarily prolonging the time to reach the maintenance dose. Day 3 increases this dose to a higher maintenance dose as part of the graded introduction method. Day 4 repeats Day 3's dose for promotion of tolerance as well as for identification of delayed reactions. The exposure dose of the cow's milk powder protein will preferably be given for two days and will range between about 0.1 and 0.7 grams, with the exposure dose being increased after two days to the maintenance dose, which will range between about 0.3 and 1.5 grams. Day 5 includes the previous maintenance dose of cow's milk protein, with the addition of an exposure dose of cooked chicken egg white protein. Day 6 includes the previous maintenance dose of cow's milk protein, and repeats Day 5's dose of cooked chicken egg white protein for promotion of tolerance as well as for identification of delayed reactions. Days 7 and 8 include the previous maintenance dose of cow's milk protein with the addition of a maintenance dose of cooked chicken egg white protein. The exposure dose of the cooked chicken egg white powder protein will preferably be given for two days and will range between about 0.01 and 0.1 grams, with the exposure dose being increased after two days to the maintenance dose, which will range between about 0.05 and 0.5 grams. Days 9 and 10 include the previous maintenance doses of cow's milk protein and cooked chicken egg white protein, with the addition of an exposure dose of peanut protein which will range between about 0.05 and 0.3 grams. For days 11 and 12, the packets will include the previous maintenance doses of cow's milk protein and cooked chicken egg white protein, with the addition of a maintenance dose of peanut protein which will range between about 0.1 and 0.9 grams. Days 13 and 14 include the previous maintenance doses of cow's milk protein, cooked chicken egg white protein, and peanut protein with the addition of an exposure dose of wheat protein which will range between about 0.05 and 0.5 grams. For days 15 and 16, the packets will include the previous maintenance doses of cow's milk protein, cooked chicken egg white protein, and peanut protein with the addition of a maintenance dose of wheat protein which will range between about 0.2 and 1.0 grams. Days 17 and 18 include the previous maintenance doses of cow's milk protein, cooked chicken egg white protein, peanut protein, and wheat protein with the addition of an exposure dose of soy protein which will range between about 0.05 and 0.5 grams. For days 19 and 20, the packets will include the previous maintenance doses of cow's milk protein, cooked chicken egg white protein, peanut protein, and wheat protein with the addition of a maintenance dose of soy protein which will range between about 0.2 and 1.0 grams. Days 21 and 22 include the previous maintenance doses of cow's milk protein, cooked chicken egg white protein, peanut protein, wheat protein, and soy protein, with the addition of an exposure dose of sesame protein which will range between about 0.05 and 0.5 grams. For days 23 and 24, the packets will include the previous maintenance doses of cow's milk protein, cooked chicken egg white protein, peanut protein, wheat protein, and soy protein with the addition of a maintenance dose of sesame protein which will range between about 0.2 and 1.0 grams. Days 25 and 26 include the previous maintenance doses of cow's milk protein, cooked chicken egg white protein, peanut protein, wheat protein, soy protein, and sesame protein with the addition of an exposure dose of walnut protein which will range between about 0.05 and 0.5 grams. For days 27 and 28, the packets will include the previous maintenance doses of cow's milk protein, cooked chicken egg white protein, peanut protein, wheat protein, soy protein, and sesame protein with the addition of a maintenance dose of walnut protein which will range between about 0.2 and 1.0 grams. Days 29 and 30 include the previous maintenance doses of cow's milk protein, cooked chicken egg white protein, peanut protein, wheat protein, soy protein, sesame protein, and walnut protein with the addition of an exposure dose of cashew protein which will range between about 0.05 and 0.5 grams. For days 31 and 32, the packets will include the previous maintenance doses of cow's milk protein, cooked chicken egg white protein, peanut protein, wheat protein, soy protein, sesame protein, and walnut with the addition of a maintenance dose of cashew protein which will range between about 0.2 and 1.0 grams. Days 33 and 34 include the previous maintenance doses of cow's milk protein, cooked chicken egg white protein, peanut protein, wheat protein, soy protein, sesame protein, walnut protein, and cashew protein with the addition of an exposure dose of almond protein which will range between about 0.05 and 0.5 grams. For days 35 and 36, the packets will include the previous maintenance doses of cow's milk protein, cooked chicken egg white protein, peanut protein, wheat protein, soy protein, sesame protein, walnut protein with the addition of a maintenance dose of almond protein which will range between about 0.2 and 1.0 grams.

[0045] After completion of graded introduction of the nine proteins by day 36, at day 37 and thereafter, a maintenance dosing of milk protein, cooked chicken egg white protein, peanut protein, wheat protein, soy protein, sesame protein, walnut protein, and almond is achieved, and represents the maintenance phase of the system. Once the maintenance dose of all nine proteins is reached (day 35 and 36), all subsequent packets of the product will continue to include the maintenance doses of all the allergen containing powders.

[0046] While FIG. 4 shows an exemplary embodiment of a formulation having nine different allergens, the allergens can be changed, and the order of their introduction can also be changed. For example, the order of administration of cashew powder and almond powder can be switched. The same applies to other allergens.

[0047] Referring back to FIG. 2, it describes a kit with powders containing five allergens, viz., cow's milk, cooked chicken egg white, peanut, wheat, and soy. However, other kits are contemplated which consist of other noted food allergens, including the kit of FIG. 4 with nine different allergens. However, regardless of the kit, each allergen will be introduced in a first introductory, lower dose, which after at least one day, and preferably two days, will be increased to a higher maintenance dose. It is also possible that an intermediate dose be given, or that the maintenance dose can be increased gradually in additional steps.

[0048] While FIG. 2 shows the kit as including separately marked packets for days, after the last allergen in the series has been introduced and is being administered at its maintenance dose, there is no need to provide the allergens in individual day-numbered packets as there will be no further change in the composition of the ingredients. Thus, the final maintenance does formulation can be provided in a bulk container, e.g., a tub, a jar, a re-sealable sliding channel/zipper storage bag, etc., wherein a mixture of all nine allergens at their higher maintenance dose are present at a proper volumetric ratio to maintain a correct dose of each of the separate allergens when a given volume of the mixture of the allergens is collected, e.g., a scoop of powder, for administration to an infant. If necessary, the mixture of all nine allergens can be included a carrier powder that create additional bulk, resistance to caking, and better flow control, and/or dissolvability in liquids or other foods and the appropriate amount of powder can be measured out by the consumer, e.g., by a scoop sized to deliver the correct amount multi-allergen powder.

[0049] In another preferred embodiment of the invention, the multiple allergen early introduction system comprising daily dietary supplements for use in a stepwise program of daily use, administered to infants. However, unlike the earlier described embodiment, the dietary supplements are pre-incorporated in the appropriate doses in infant formula, in solid foods (e.g., baby food in jars, pouches, cookies and snack bars and the like, and other food items), or in pre-dosed gel packs so that the caregiver does not need to mix separate supplements into the food. As in the earlier described embodiment, the daily program incorporates increases in protein exposure, sequential introduction, and promotion of tolerance. First exposure formulations use protein amounts determined to be in a range of low provoking doses, as established in the medical literature. By utilizing low provoking doses, reactions if they do occur are significantly more likely to be mild in nature. In the event of any reaction, including but not limited to rashes or gastrointestinal upset, parents and other caregivers are able to present an exact description of exposure history to their pediatrician or allergist. After it has been confirmed that the exposure dose of a particular protein is well tolerated, the infant will continue to be administered the infant formula, solid foods, or the pre-dosed gel packs packets containing the protein(s), which subsequent infant formula, solid foods, or the pre-dosed gel packs packets containing the protein(s) will include a higher, “maintenance” dose of the now cleared protein. Thus, each day's food with the supplement involves either 1) duplication of previous allergen amounts to promote tolerance and allow for detection of delayed reactions, 2) increase of previous allergen amount to achieve maintenance dosing levels, or 3) addition of a new food allergen for sequential introduction. Once the food with an allergen has been introduced, it is included in all subsequent days of the guided program.

[0050] The “exposure” phase involves graded increases in allergen amount as well as sequential introduction of new allergens. Once maintenance levels of each have been attained, continuation at these levels is done through daily administration during the “maintenance” phase of the food.

[0051] An exemplary introduction kit contains a 30-day supply consisting of daily food items containing the supplements for both the exposure and maintenance phase. Continuation kits contain the maintenance phase food with formulations only that can also be provided.

[0052] The formulations and duration of the exposure phase depends on the number and type of allergens introduced. The dosing of the various allergens can follow the same exemplary dosing chart as provided in FIG. 1 for a three-allergen introduction system. Again, FIG. 1 is illustrative, and the guided system is not limited to a three-allergen system and the method described above applies to additional allergens as well.

[0053] As discussed, the invention has many different features, variations and multiple different embodiments. The invention has been described in this application at times in terms of specific embodiments for illustrative purposes and without the intent to limit or suggest that the invention conceived is only one particular embodiment. It is to be understood that the invention is not limited to any single specific embodiments or enumerated variations. Many modifications, variations and other embodiments of the invention will come to mind of those skilled in the art to which this invention pertains, and which are intended to be and are covered by both this disclosure. It is indeed intended that the scope of the invention should be determined by proper interpretation and construction of the disclosure, including equivalents, as understood by those of skill in the art relying upon the complete disclosure at the time of filing.

[0054] The disclosed method and kit is unique when compared with other known methods and kits solutions because it provides an opportunity for early introduction of multiple allergens to infants even prior to when they may be developmentally ready for solid food, via easy suspension in breast milk or infant formula, or provided already mixed in with food. The use of multiple allergens addresses the majority of food allergy causes rather than just one allergen. As noted above, the preferred embodiment with the three common allergens in cow's milk, hen's egg whites, and peanuts, represents the foods responsible for >80% of childhood food allergy. Similarly, the method is unique in that introduction is in a graded dose increase fashion, facilitating prompt and early identification of potential allergic reactions which if they occur, are more likely to be mild. Similarly, the disclosed method is unique when compared with other known processes and solutions in that multiple allergens are introduced in a sequential fashion, so the specific food allergen involved in potential reactions can be identified.

[0055] The disclosed kit is unique in that it is structurally different from other known devices or solutions. More specifically, the kit is unique due to the presence of multiple allergens within the maintenance phase of the guided system kit. The daily formulations consist of unique and distinct doses to achieve sequential as well as graded introduction, based on protocols from the early introduction literature. The components of the daily powders are of sufficiently low particle size, in particular less than about 200 microns, to allow for easy passage through infant bottle nipples. Furthermore, the formulations are specifically designed and tested to allow for easy mixing with breast milk or infant formula. Regarding the kit, a variety of verbal and pictorial instructions allow for easy compliance with the sequence of daily administration.

[0056] Furthermore, the process and method of using the kit is likewise unique. More specifically, the disclosed process and method owes its uniqueness to the fact that it provides families with detailed information on the precise identity and amount of food allergen exposure, in the event of adverse food reactions, to be provided to relevant healthcare professionals. Based on the day of the program, families know exactly which food allergens have been administered, how much, and when. Any other approach that does not stagger the introduction of individual allergens over a time series would not offer this benefit of tracing adverse reactions to their cause.

[0057] The preferred embodiments of this invention have been disclosed, however, so that one of ordinary skill in the art would recognize that certain modifications would come within the scope of this invention.