Method of making a consumable product with purified embryonated Trichuris suis ova

Abstract

A method of making a consumable product containing purified embryonated Trichuris suis ova (TSO) preferably includes steps of: storing the TSO in an acidic solution; adding a food preservative to the acidic solution to produce a preservative-acid-solution; forming a mixing solution by raising the pH of the preservative-acidic-solution to match the pH of a food substance by titrating the preservative-acidic-solution with an acid neutralizer so that the pH changes at a rate of not more than 1 pH unit per 24 hours, preferably to a pH not higher than 5.0; and producing the consumable product by combining the mixing solution and the food substance while maintaining the temperature of the consumable product between 1 degree Centigrade and 47 degrees Centigrade.

Claims

1. A method of making a consumable product, the consumable product comprising a purified embryonated Trichuris suis ova, the method comprising the steps of: storing a purified embryonated Trichuris suis ova in an acidic solution; adding a food preservative to the acidic solution to produce a preservative-acid-solution; selecting a food substance with a pH number greater than the pH of the preservative acid solution; forming a mixing solution by raising the pH of the preservative-acidic-solution to match the pH of the food substance by titrating the preservative-acidic-solution with an acid neutralizer so that the pH changes at a rate of not more than 1 pH unit per 24 hours; and producing the consumable product by combining the mixing solution and the food substance, said producing performed while maintaining the temperature of the consumable product between 1 degree Centigrade and 47 degrees Centigrade.

2. The method of claim 1, further comprising the step of making the acidic solution using a formulation selected from the group consisting of vinegar, phosphoric acid, acetic acid, and citric acid.

3. The method of claim 1, further comprising the step of selecting the food preservative from at least one of sodium citrate, sodium sorbate, and sodium benzoate.

4. The method of claim 3, further comprising the step of limiting the sodium sorbate to a concentration of less than 0.3% sorbate in the acid solution.

5. The method of claim 3, further comprising the step of limiting the sodium benzoate to a concentration of about 0.1% in the acidic solution.

6. The method of claim 1, further comprising the step of choosing the food substance having a maximum pH of 5.0.

7. The method of claim 1, further comprising the steps of: selecting the food substance from the group consisting of water, a flavored drink, a juice, a dressing, a pudding, a yogurt, a gelatin, a frosting, and honey; and utilizing a targeted quantity of Trichuris suis ova in the acidic solution.

8. The method of claim 7, further comprising the step of limiting the targeted quantity to number within a range of 250 to 2500 viable Trichuris suis ova per food product.

9. The method of claim 1, further comprising the step of forming an edible coating on a portion of the mixing solution, wherein the portion contains a number of Trichuris suis ova per unit of weight.

10. The method of claim 9, further comprising the step of selecting the coating from the group consisting of chocolate, wax, and polymer.

11. The method of claim 1, further comprising the step of adding a flavoring to the consumable product.

12. The method of claim 1, further comprising the step of minimizing mechanical stirring when combining the mixing solution and the food substance.

13. A method of using the consumable product made by the method of claim 1, the method comprising the step of feeding the consumable product to a human or a non-human animal.

Description

BRIEF DESCRIPTION OF DRAWINGS

(1) The drawings illustrate preferred and optional steps in the method of making a consumable product with purified embryonated Trichuris suis ova according to the disclosure. The reference numbers in the drawings are used consistently throughout. Reference numbers in FIG. 1 are given 100 series numbers. Similarly, new reference numbers in FIG. 2 are given the 200 series numbers.

(2) FIG. 1 is a flow chart of the steps of a preferred embodiment of the method of making the consumable product with purified embryonated Trichuris suis ova.

(3) FIG. 2 is a chart showing optional steps in alternative embodiments.

DESCRIPTION OF EMBODIMENTS

(4) In the following description, reference is made to the accompanying drawings, which form a part hereof and which illustrate several embodiments of the present invention. The drawings and the preferred embodiments of the invention are presented with the understanding that the present invention is susceptible of embodiments in many different step combinations and, therefore, other embodiments may be utilized and operational changes may be made, without departing from the scope of the present invention.

(5) Reference is made to FIG. 1 showing steps in a preferred embodiment of the method of making a consumable product with purified embryonated Trichuris suis ova (TSO). The consumable product, is also referred to as a food product, and it includes any substance consumed by a human, including as typical examples water, flavored drinks, juices, dressings, puddings, yogurt, gelatin, frostings, honey and dietary supplements.

(6) This preferred embodiment is method of making (100) a consumable product, the consumable product comprising a purified embryonated Trichuris suis ova. The method includes a storing step (105); a first-adding step (110); a first-forming step (115); and a producing step (120).

(7) The storing step (105) includes storing a purified embryonated Trichuris suis ova in an acidic solution. A preferable acidic solution uses vinegar with a 4% acetic acid. Vinegar is a liquid consisting mainly of acetic acid (CH.sub.3COOH) and water. Acetic acid is usually produced by the fermentation of ethanol by acetic acid bacteria. Vinegar is preferred because it is itself a food product and it comprises a mild acid that is less likely to damage the TSO.

(8) The first-adding step (110) includes adding a food preservative to the acidic solution to produce a preservative-acid-solution. Exemplary food preservatives include sodium citrate, sodium sorbate, and sodium benzoate, calcium propionate, sodium nitrate, sodium nitrite, disodium EDTA, and sulfites such as sulfur dioxide, sodium bisulfite, and potassium hydrogen sulfite.

(9) The food preservative lengthens the shelf life of the consumable product, preferably so that if stored at a temperature within a specified temperature range of 1 C. to 47 C., the consumable product can be utilized throughout the testing period. The food preservative is also a widely used consumable product and so it is not something that will contaminate the consumable product resulting from the disclosed method.

(10) The first-forming step (115) includes forming a mixing solution by raising the pH of the preservative-acidic-solution to match the pH of a food substance by titrating the preservative-acidic-solution with an acid neutralizer so that the pH changes at a rate of not more than 1 pH unit per 24 hours, optionally for a food substance having a maximum pH of 5.0. Thus, the first-forming step (115) may be accomplished with the choosing step (260) of choosing the food substance having a maximum pH of 5.0.

(11) The pH number is a figure expressing the acidity or alkalinity of a solution on a logarithmic scale on which a number between 0 and 14 indicates if a chemical is an acid or a base. On this scale, a pH of less than 7 represents acidity, a pH of 7 indicates neutrality, and a pH of more than 7 represents alkalinity. Thus, a pH of 7 represents a neutral solution, lower values are more acid, and higher values more alkaline. The pH is the negative of the logarithm to base 10 of the concentration of hydrogen ions in moles per liter. The pH may be mathematically shown as equal to log.sub.10 c, where c is the hydrogen ion concentration in moles per liter.

(12) The producing step (120) includes producing the consumable product by combining the mixing solution and the food substance, said producing performed while maintaining the temperature of the consumable product between 1 degree Centigrade and 47 degrees Centigrade.

(13) FIG. 2 illustrates optional steps in the method. The dotted line connecting the boxes showing the steps is intended to signify that each of the steps is optional. The optional steps include a making step (205); a first-selecting step (210); a first-limitation step (215); a second-limitation step (220); a second-selecting step (225); a third-limiting step (230); a second-forming step (235); a third-selecting step (240); a second-adding step (245); a minimizing step (250); and a feeding step (255).

(14) The making step (205) includes of making the acidic solution using a formulation selected from the group consisting of vinegar, phosphoric acid, acetic acid, and citric acid. These acids are commonly found in food products. Phosphoric acid is commonly found in soft drinks to provide a sharper, tangy taste and to help slow the growth of molds and bacteria in sugary formulas. Acetic acid is the main component of vinegar and is thus a consumable food. Citric acid is a weak organic tribasic acid: It occurs naturally in citrus fruits. Use of an acid that is commonly consumed in foods is preferred for the making step (205).

(15) The first-selecting step (210) includes of selecting the food preservative from at least one of sodium citrate, sodium sorbate, and sodium benzoate.

(16) The first-limitation step (215) includes of limiting the sodium sorbate to a concentration of less than 0.3% sorbate in the acid solution.

(17) The second-limitation step (220) includes of limiting the sodium benzoate to a concentration of about 0.1% in the acidic solution.

(18) The second-selecting step (225) includes of selecting the food substance from the group consisting of water, a flavored drink, a juice, a dressing, a pudding, a yogurt, a gelatin, a frosting, and honey; and utilizing a targeted quantity of Trichuris suis ova in the acidic solution. Use of a liquid or soft food substance makes it easier to combine the mixing solution containing the TSO with the food substance while minimizing mechanical disruption of the combination.

(19) The third-limiting step (230) includes of limiting the targeted quantity to number within a range of 250 to 2500 viable Trichuris suis ova per food product. This covers the range of egg content that is used in the clinical trials and testing.

(20) The second-forming step (235) includes of forming an edible coating on a portion of the mixing solution, wherein the portion contains a number of Trichuris suis ova per unit of weight. An edible coating can make administering the food product much more pleasing to the test subject.

(21) The third-selecting step (240) includes of selecting the coating from the group consisting of chocolate, wax, and polymer.

(22) The second-adding step (245) includes of adding a flavoring to the consumable product. A flavoring can make the food product enjoyable to consume.

(23) The minimizing step (250) includes of minimizing mechanical stirring when combining the mixing solution and the food substance.

(24) The feeding step (255) includes of feeding the consumable product to a human or a non-human animal. Thus the feeding step (255) is a method of using the consumable product.

(25) The above-described embodiments including the drawings are examples of the invention and merely provide illustrations of the invention. Other embodiments will be obvious to those skilled in the art. Thus, the scope of the invention is determined by the appended claims and their legal equivalents rather than by the examples given.

INDUSTRIAL APPLICABILITY

(26) The invention has application to the human and animal health food and pharmaceutical industries.