Anti-regurgitation composition maintaining gut motility

Abstract

The present invention relates to nutritional compositions intended to prevent or treat regurgitations in infants and young children without altering, or even improving, their gut motility and/or for preventing and/or treating intestinal disorders of the infant or child. The invention also concerns the process for manufacturing this composition.

Claims

1. A method for treating regurgitation and/or reflux and improving or maintaining gut motility, the method comprising administering to an infant or a child an effective amount of a nutritional composition comprising cold-soluble carob and at least two pectins of different natures.

2. The method of claim 1, wherein the nutritional composition is a milk for infants or children.

3. The method of claim 2, wherein the milk for infants or children is a powder milk.

4. The method of claim 1, wherein gut motility anomalies or disorders comprise constipation, soft stools, diarrhea, colics.

5. The method of claim 1, wherein cold-soluble carob has solubility of more than 60% in an aqueous medium at a temperature between 10 C. and 45 C.

6. The method of claim 1, wherein the concentration of cold-soluble carob is less than or equal to about 1% by weight based on the total weight of the composition.

7. The method of claim 1, wherein the pectins are highly methylated, weakly methylated pectins, or a mixture of both.

8. The method of claim 1, wherein the composition further comprises starch.

9. The method of claim 1, wherein the composition further comprises carbohydrates, said carbohydrates being lactose and/or maltodextrins; lipids; proteins, said proteins being either hydrolyzed or unhydrolyzed; and/or amino acids.

10. The method of claim 1, wherein the composition has a viscosity between 1,600 mPa.Math.s and 150 mPa.Math.s when the pH is between 6 and 3.5.

11. The method of claim 1, wherein the composition comprises cold-soluble carob at a percentage of less than about 1% by weight; weakly methylated amidated pectins at a concentration between about 4% and about 5% by weight; highly methylated pectins at a concentration of about 1% by weight; said percentages being expressed by weight based on the total weight of the composition.

Description

LEGEND OF THE FIGURES

(1) FIG. 1:

(2) Atable of the viscosity of the composition versus pH

(3) Bviscosity graph of the composition according to the invention versus pH

EXAMPLES

Example 1

Formulation

(4) The formulation of milks intended for infant feeding is most often strictly restricted by legislation setting composition standards. Depending on the countries, there may be differences of appreciation notably because of local specificities in the practice of food diversification or else minor modifications of the nutritional optima resulting from locally conducted investigations or studies. Under these conditions, the present example does not intend to represent the diversity of the thickened milk formulations according to the invention.

(5) Conventionally, in order to meet the nutritional needs of infants, infant milks comprise about 10-15% of proteins, about 25% of lipids and about 50-65% of carbohydrates as well as minerals, vitamins and optionally growth factors. Other ingredients such as one or several prebiotics and/or probiotics may moreover be added to infant milks.

(6) A non-limiting example of a composition of the anti-regurgitation and/or anti-reflux infant milk type preserving gut motility according to the invention is provided in Table I below.

(7) TABLE-US-00001 TABLE I For 100 g For 100 ml of 13% Composition/Nutritional profile: of powder reconstituted milk Proteins Nx 6.25 g 12.1 1.57 Lipids g 25.1 3.26 Carbohydrates g 53 6.89 Maltodextrins g 26 3.38 Lactose g 22 2.86 Starch g 0.9 0.12 Dextrose g 3.4 0.44 HM pectin g 1 0.13 Amidated LM pectin g 4.25 0.55 Cold-soluble carob g 0.5 0.07 Energy kcal 493.7 64.18 Minerals Sodium mg 180 23.40 Potassium mg 520 67.60 Chlorine mg 345 44.85 Calcium mg 460 59.80 Phosphorus mg 340 44.20 Magnesium mg 45 5.85 Iron mg 6 0.78 Zinc mg 3.5 0.46 Iodine g 55 7.15 Copper g 350 45.50 Manganese g 45 5.85 Selenium g 9 1.17 Chromium g <45 <5.85 Molybdenum g <45 <5.85 Fluorine g <450 <58.5 Vitamins A g RE 450 58.50 B1 g 400 52.00 B2 g 800 104.00 B6 g 300 39.00 B12 g 1.5 0.20 C mg 60 7.80 D g 7.5 0.98 E IU 16.4 2.13 K1 g 30 3.90 Biotin g 15 1.95 Niacin mg 4.5 0.59 Folic acid g 60 7.80 Pantothenic acid mg 2.4 0.31 Choline mg 60 7.80 Inositol mg 30 3.90 Taurine mg 44 5.72 L-carnitine mg 8 1.04

(8) In the present composition, the starch, in particular the pre-cooked and/or pre-gelatinized starch present at a low content, has no influence on the effectiveness of the formula, in particular on its viscosity.

(9) Indeed, upon manufacturing the compositions according to the invention, the starch, in particular the pre-cooked and/or pre-gelatinized starch, when it is present, undergoes, like all of the ingredients making up the composition, in particular the liquid base, a step for heating to a temperature of at least 60 C., followed by homogenization by fractionation of the constitutive elements of the composition, in particular the liquid base, during a first step i) carried out under a pressure comprised between 100 and 300 bars and a step ii) carried out under a pressure comprised between 10 and 60 bars. Such treatments inhibit or suppress any capability of the starch to thicken and to impact the viscosity of the compositions according to the invention which would comprise starch.

Example 2

Process for Manufacturing a Pasteurized Infant Milk as a Powder Comprising i) Cold-Soluble Carob and ii) at Least Two Pectins of Different Natures

(10) The infant milk base comprising 37% of dry extract is prepared by mixing water heated beforehand to 70 C. with the different infant milk ingredients (said ingredients comprising proteins or amino acids+cold-soluble carob+weakly esterified pectins or weakly esterified and amidated pectins+highly esterified pectins+carbohydrates+minerals+plant fats+vitamins+growth factors). The carob and pectins are incorporated into the infant milk base maintained with stirring in order to obtain their complete dissolution. The whole is maintained at 70 C. with stirring in a double-walled chamber until the homogenization step. The infant milk base then undergoes dual effect homogenization at 200/40 bars, i.e., a first homogenization step is carried out under a pressure of 200 bars and a second homogenization step is carried out under a pressure of 40 bars. The homogenized infant milk base is then preferably pasteurized by heat treatment at about 80 C. for 1 to 2 minutes with the purpose of removing bacteriological risks, in particular those related to Cronobacter sakazakii.

(11) The infant milk base, preferably pasteurized, then undergoes an atomization step carried out under a pressure of 190 bars which allows obtaining droplets with a sufficiently small diameter so as to be dried with air, the temperature of which at the inlet of the chamber is 185 C. and the temperature at the outlet of the chamber is 94 C.

(12) The applied process here allows obtaining a throughput of 1,000 and 2,000 kg of powder/hour.

(13) The reconstituted liquid milk (ready to be consumed) obtained from this infant milk powder has a dry extract of about 13% in the baby bottle. The viscosity of this reconstituted milk, measured at 60 rpm (revolutions per minute), at 37 C., is comprised between 25-45 mPa.Math.s (S61 mobile) at a pH close to neutral and comprised between 1,502 and 145 mPa.Math.s for a pH ranging from 6 to 3.5. The reconstituted liquid milk contains 0.68% of pectins and 0.065% of carob in the baby bottle.

Example 3

Comparison Between the Viscosity of a Reconstituted Milk Comprising a Milk in Powder Form According to the Invention with the Viscosity of a Conventional AR Milk Containing Starch (Novalac AR)

(14) An infant milk according to the invention is produced and collected as a powder according to the manufacturing process mentioned in Example 2. This milk according to the invention thus comprises 4.25% of weakly esterified pectins and weakly esterified and amidated pectins, 1% of highly esterified pectins and 0.5% of cold-soluble carob.

(15) Method and Tools

(16) The liquid infant milk is then prepared, by dilution of the infant milk as a powder according to the invention in hot water (at 60 C.) with 13% of dry extract. Said liquid infant milk is then cooled to 37 C.

(17) The conventional AR milk based on starch is also prepared by diluting the powder in water (also at 37 C.) with 13% of dry extract.

(18) The viscosities of both products are then measured by means of a Brookfield viscosimeter (DV-I Prime) at the reconstitution pH (close to neutral) with an S61 mobile at 60 rpm (revolutions per minute) and at a temperature of 37 C.

(19) Hydrochloric acid, with a molarity equal to 1 (HCl 1M), is added to both reconstituted products in order to attain a pH of 5.5. The viscosities of both acidified products are then measured at 37 C., with an S61 mobile and at a rate of 60 rpm for the Novalac AR product and with an S62 mobile and at a rate of 30 rpm for the infant milk formula according to the invention.

(20) Then hydrochloric acid, with a molarity equal to 1 (HCl 1M), is again added to both reconstituted products in order to attain a pH of 3.5. The viscosities of both acidified products are then again measured at 37 C., with an S62 mobile and at a rate of 60 rpm.

(21) TABLE-US-00002 TABLE 3 Viscosities in mPa .Math. s AR products Neutral pH pH = 5.5 pH = 3.5 Novalac AR 10 96 241 Infant milk according to 36 645 145 the invention
Conclusion:

(22) The significant increase in viscosity, observed as soon as pH=6, in particular at pH=5.5, of the infant milk according to the invention will provide significant effectiveness against regurgitations and/or reflux of the infant or child. Indeed, the pH of the stomach of the infant 15 mins after ingestion of a milk is generally found to be between 6 and 5. Therefore it is actually seen that conventional Novalac AR milk, for which the viscosity is of about 100 mPa.Math.s, will have a lesser effect on regurgitations and/or reflux: the more viscous the product, the more the regurgitations and/or reflux will decrease.

Example 4

Comparison Between the Viscosity of a Reconstituted Milk Comprising a Milk as a Powder According to the Invention with the Viscosity of an AR Milk Containing Starch and Cold-Soluble Carob (Novalac AR Digest)

(23) An infant milk according to the invention is produced and collected as a powder according to the manufacturing process mentioned in Example 2. This milk according to the invention thus contains 4.25% of weakly esterified pectins and weakly esterified and amidated pectins, 1% of highly esterified pectins and 0.5% of cold-soluble carob.

(24) Method and Tools

(25) The liquid infant milk according to the invention is then produced, by diluting the infant milk as a powder according to the invention in hot water (at 60 C.) with 13% of dry extract. Said liquid infant milk is then cooled to 37 C.

(26) The AR-Digest milk based on starch and on cold-soluble carob is also prepared by diluting the powder in water (also at 37 C.) with 13% of dry extract.

(27) The viscosities of both products are then measured by means of a Brookfield viscosimeter (DV-I Prime) at the reconstitution pH (close to neutral) with an S61 mobile at 60 rpm (revolutions per minute) and at a temperature of 37 C.

(28) Hydrochloric acid, with a molarity equal to 1 (HCl 1M), is added to both reconstituted products in order to attain a pH of 5.5. The viscosities of both acidified products are then measured at 37 C., with an S62 mobile at a rate of 60 rpm for the Novalac AR-Digest product and at a rate of 30 rpm for the infant milk formula according to the invention.

(29) Then hydrochloric acid, with a molarity equal to 1 (HCl 1M), is again added to both reconstituted products in order to attain a pH of 3.5. The viscosities of both acidified products are then again measured at 37 C., with an S62 mobile and at a rate of 60 rpm.

(30) TABLE-US-00003 TABLE 4 Viscosities in mPa .Math. s AR products pH neutral pH = 5.5 pH = 3.5 Novalac AR Digest (hydrolyzed 18 108 210 proteins + cold-soluble carob (4%)) Infant milk according to the invention 36 645 145
Conclusion

(31) Like in Example 3, it is seen here that the infant milk according to the invention allows greater effectiveness as to the decrease of regurgitations and/or reflux of the infant or child at pHs comprised between 6 and 5 (pH of the infant's stomach about 15 minutes after ingesting an infant milk).

Example 5

Comparison Between the Viscosity of a Reconstituted Milk Comprising a Milk as a Powder According to the Invention Obtained by Dry Mixing with the Viscosity of a Conventional AR Milk Thickened by Means of Starch and Cold-Soluble Carob (Novalac AR Digest)

(32) An infant milk base is produced and collected as a powder at the outlet of the drying tower. To this base as a powder are then added, by dry mixing, 4.25% of weakly esterified pectins or weakly esterified and amidated pectins, 1% of highly esterified pectins and 0.5% of cold-soluble carob.

(33) Method and Tools

(34) The liquid infant milk is then produced by diluting the infant milk as a powder according to the invention in hot water (at 60 C.) with 13% of dry extract. Said liquid infant milk is then cooled to 37 C.

(35) The AR-Digest milk based on starch and cold-soluble carob is also prepared by diluting the powder in water (also at 37 C.) with 13% of dry extract.

(36) The viscosities of both products are then measured by means of a Brookfield viscosimeter (DV-I Prime) at the reconstitution pH (close to neutral) with an S61 mobile at 60 rpm (revolutions per minute) and at a temperature of 37 C.

(37) Hydrochloric acid with a molarity equal to 1 (HCl 1M) is added to both reconstituted products in order to attain a pH of 5.5. The viscosities of both acidified products are then measured at 37 C., with an S62 mobile at a rate of 60 rpm for the Novalac AR-Digest product and at a rate of 30 rpm for the infant milk formula according to the invention.

(38) Next, hydrochloric acid, with a molarity equal to 1 (HCl 1M), is again added to both reconstituted products in order to attain a pH of 3.5. The viscosities of both acidified products are then again measured at 37 C., with an S62 mobile and at a rate of 60 rpm.

(39) TABLE-US-00004 TABLE 5 Viscosities in mPa .Math. s AR products neutral pH pH = 5.5 pH = 3.5 Novalac AR Digest (cold-soluble 18 108 210 carob (4%) + starch) Infant milk according to the invention 25 530 125 obtained by dry mixing
Conclusion

(40) Like in the previous example, the infant milk according to the invention allows greater effectiveness as to the reduction of regurgitations and/or reflux of the infant or child at a pH comprised between 6 and 5 (pH of the stomach of the infant 15 minutes after ingestion of an infant milk).

Example 6

Evaluation of the Clinical Effectiveness on Regurgitations and the Effect on Gut Motility of a Reconstituted Milk Obtained from a Composition as a Powder According to the Invention

(41) An open clinical study was conducted in order to determine the influence of a reconstituted milk obtained from a composition, typically from a milk, as a powder according to the invention on the frequency and intensity of the episodes of regurgitations and/or refluxes as well as on gut motility, in particular on the consistency of the stools of infants. This clinical study was conducted over a period of 14 days plus or minus 2 days, i.e., over a period ranging from 12 to 16 days between the day of the first visit or inclusion day, noted as D0, and the day of the second visit, about 14 days later, at plus or minus two days, noted as D14.

(42) Method and Tools

(43) A composition according to the invention for which the nutritional profile corresponds to that of Table II below was prepared and collected as a powder.

(44) TABLE-US-00005 TABLE II For 100 g For 100 ml of 13% Composition/Nutritional profile: of powder reconstituted milk Proteins Nx 6.25 g 12.1 1.57 Lipids g 25.1 3.26 Carbohydrates g 53 6.89 HM pectin g 1 0.13 Amidated LM pectin g 4.25 0.55 Cold-soluble carob g 0.5 0.07 Energy kcal 493.7 64.18 Minerals Sodium mg 180 23.40 Potassium mg 520 67.60 Chlorine mg 345 44.85 Calcium mg 460 59.80 Phosphorus mg 340 44.20 Magnesium mg 45 5.85 Iron mg 6 0.78 Zinc mg 3.5 0.46 Iodine g 55 7.15 Copper g 350 45.50 Manganese g 45 5.85 Selenium g 9 1.17 Chromium g <45 <5.85 Molybdenum g <45 <5.85 Fluorine g <450 <58.5 Vitamins A g RE 450 58.50 B1 g 400 52.00 B2 g 800 104.00 B6 g 300 39.00 B12 g 1.5 0.20 C mg 60 7.80 D g 7.5 0.98 E IU 16.4 2.13 K1 g 30 3.90 Biotin g 15 1.95 Niacin mg 4.5 0.59 Folic acid g 60 7.80 Pantothenic acid mg 2.4 0.31 Choline mg 60 7.80 Inositol mg 30 3.90 Taurine mg 44 5.72 L-carnitine mg 8 1.04

(45) For this, an infant milk base comprising 37% of dry extract is prepared by mixing water heated beforehand to 70 C. with the different ingredients of the infant milk (said ingredients comprising proteins or amino acids+cold-soluble carob+weakly esterified pectins or weakly esterified and amidated pectins+highly esterified pectins+carbohydrates+minerals+plant fats+vitamins+growth factors). The carob and the pectins are incorporated into the infant milk base maintained with stirring in order to obtain their complete dissolution. The whole is maintained at 70 C. with stirring in a double-walled chamber until the homogenization step. The infant milk base is then pasteurized by heat treatment at about 80 C. for 1 to 2 minutes with the purpose of suppressing bacteriological risks, in particular those related to Cronobacter sakazakii. The pasteurized infant milk base is then subjected to dual effect homogenization at 200/40 bars, i.e., a first homogenization step is carried out under a pressure of 200 bars and a second homogenization step is carried out under a pressure of 40 bars.

(46) The pasteurized and homogenized infant milk base then preferably undergoes an atomization step carried out under a pressure of 140 bars which allows obtaining droplets with a sufficiently small diameter so as to be dried with air, the temperature of which at the inlet in the chamber is 185 C. and the temperature at the outlet of the chamber is comprised between 80 and 105 C., in particular equal to 94 C.

(47) The applied process here allows obtaining a throughput of 1,000 and 2,000 kg of powder/hour.

(48) The obtained composition as a powder is then conditioned in boxes. This composition according to the invention thus comprises 4.25% of weakly esterified and amidated pectins, 1% of highly esterified pectins and 0.5% of cold-soluble carob.

(49) The concentration of non-hydrolyzed proteins is advantageously of about 9% by weight (preferably about 7.2% of whole caseins and 1.8% of soluble whole proteins) and the concentration of hydrolyzed proteins is advantageously of about 3% by weight (preferably exclusively soluble proteins), based on the total weight of the composition.

(50) In order to be estimated as admissible for this study, the infants should be at most 5 months old, be exclusively fed with an infant formula, have at least 5 regurgitation episodes per day, not have started food diversification and have no new food introduced into their diet in the 2 weeks following the inclusion.

(51) In order to be estimated as admissible for this study, the infants should also not reproduce any of the following non-inclusion criteria: be fed with mother's milk, have complicated gastro-esophageal reflux (GOR) symptoms such as nausea, dysphagia, growth retardation, or obvious signs of esophagitis, have intestinal disorders such as, notably, gastroenteritis or chronic diarrhea, have received medical treatment for regurgitations during the week preceding the inclusion (such as Omeprazole or Ranitidine), or be required to begin such a treatment, have received antibiotics during the week preceding the inclusion or require antibiotherapy, have an allergy to cow milk proteins, or have an increased risk of allergy to cow milk proteins, have a situation which according to the investigator may interfere with the conduct of the study or have a particular risk for them, or be participating in another clinical study.

(52) 100 admissible infants were recruited. Of these 100 initially recruited infants, 10 infants were excluded before D14 for reasons such as a change in opinion of the parents, suspicion of allergy to cow milk proteins, resuming breast-feeding, having lost sight of the patient, a formula a priori rejected because of its taste, suspicion of complicated GOR, and suspicion of gastroenteritis. The shown results are those associated with 90 infants included before D14, which represents 100% of the evaluated cases.

(53) The main criterion studied during this clinical study was the frequency of regurgitations, in particular the number of regurgitations per day. The regurgitations were also evaluated by means of the Vandenplas score, defined in the following way: Score=0: Less than 2 regurgitation episodes per day. Score=1: At least 3 and at most 5 regurgitation episodes of a small volume per day (less than a teaspoon per day, i.e., less than about 5 ml). Score=2: More than 5 regurgitation episodes per day, the volume of which is greater than that of a teaspoon. Score=3: More than 5 regurgitation episodes per day of about half the volume of the consumed baby bottle for less than half of the consumed baby bottles. Score=4: Continuous regurgitations of small volumes for more than 30 minutes after each baby bottle. Score=5: Regurgitations of at least half the volume of the consumed baby bottle for at least half of the consumed baby bottles. Score=6: Regurgitation of the total volume of the consumed baby bottle after each baby bottle.

(54) The Vandenplas score was used in several clinical studies to this day and is described in many scientific publications, notably in Vandenplas Y, Hachimi-Idrissi S, Casteels A, Mahler T, Loeb H. A clinical trial with an anti-regurgitation formula. Eur J Pediatr. 1994; 153(6): 419-23.

(55) One skilled in the art is aware of other scales evaluating the intensity of regurgitations, in particular the volume and/or the frequency of the regurgitations, such as Orenstein's score described in Orenstein S R, Magill H L, Brooks P. Thickening of infant feedings for therapy of gastroesophageal reflux. J Pediatr 1987; 110: 181-6.

(56) The effect on the transit was measured by evaluating the average consistency of the stools of the infants, to be selected from hard stools, formed stools, soft or liquid stools.

(57) During a first medical examination on day D0, the parents of the 100 infants signed an informed consent form, and each of the 100 infants included in the study was examined by a pediatrician-investigator who filled an observation report in which various data were reported, in particular the average number of regurgitations per day, the average consistency of the stools and the average Vandenplas score over the 3 days preceding the medical examination.

(58) During this first examination, the pediatrician handed over to the parents boxes of reconstituted milk comprising a milk as a powder according to the invention in a sufficient amount for covering the needs of the infant for 2 weeks. The reconstituted milk comprising a milk as a powder according to the invention contained in these boxes was the only food of the infants during the whole period of the study.

(59) During the whole period of the study and for each baby bottle preparation, the parents were instructed to prepare the liquid infant milk by diluting the infant milk as a powder according to the invention in water at 40 C. with 13% of dry extract and letting it cool subsequently to about 37 C. They were also instructed not to change the food habits of the infant and to continue to feed it as usual. Typically, they were instructed not to change the number or the volume of the baby bottles and to observe the food requests from the infant.

(60) At D14, i.e., about 14 days after inclusion, at plus or minus 2 days, a second medical examination took place for the 90 infants included before D14. During this examination, the pediatrician-investigator completed the observation report in which were reported various data, in particular the average number of regurgitations per day, the average consistency of the stools and the average Vandenplas score over the 3 days preceding the medical examination.

(61) Frequency of the Regurgitations

(62) Information from the observation reports of the pediatrician-investigator relating to the average number of regurgitations per day at D0 and at D14 for the 90 infants included before D14 was listed in Table 6 below.

(63) TABLE-US-00006 TABLE 6 Number of regurgitations per day Inclusion = D0 D14 Average 7.3 1.06 Standard deviation 3.4 1.25 Minimum 5 0 Maximum 20 5

(64) A reduction in the number of regurgitations was also observed between D0 and D14 in 100% of the evaluated cases. While 100% of the evaluated infants had at least 5 regurgitation episodes per day at D0, 70% of these infants had less than 0 or 1 regurgitation episode per day at D14.

(65) Conclusion

(66) These data confirm the effectiveness of a reconstituted milk comprising a composition as a powder according to the invention at reducing of the number of regurgitations and/or refluxes of the infant per day.

(67) Intensity of the Regurgitations

(68) Information from the observation reports of the pediatrician-investigator relating to the average Vandenplas score at D0 and at D14 for the 90 infants included before D14 indicates a reduction in the Vandenplas score in 99% of the cases.

(69) A reduction in the average value of the Vandenplas score was also observed between D0 and D14 which passes from 1.9 to 0.2, as indicated in Table 7 below.

(70) At D14, 77 infants, i.e., 85.5% of the 90 included infants, have a Vandenplas score of 0 and therefore have less than 2 regurgitation episodes per day.

(71) TABLE-US-00007 TABLE 7 Vandenplas score Inclusion = D0 D14 Average 1.9 0.2 Standard deviation 0.8 0.6
Conclusion

(72) These data confirm the effectiveness of a reconstituted milk comprising a milk as a powder according to the invention at reducing of the intensity of the regurgitations and/or refluxes of the infant.

(73) Gut Motility (Intestinal Transit)

(74) Information from the observation reports of the pediatrician-investigator relating to the average consistency of the stools at D0 and at D14 for the 90 infants included before D14 has been listed in Table 8 below.

(75) TABLE-US-00008 TABLE 8 Consistency of the stools Inclusion D14 Hard 14.40% 3.40% Formed 36.70% 51.10% Soft to liquid 48.90% 45.50%
Conclusion

(76) These data confirm that a reconstituted milk comprising a milk as a powder according to the invention does not alter the gut motility of the infant, and typically does not cause any undesirable effects on the stools, such as the percentage increase in constipation, diarrhea, or hard, soft, liquid and/or too frequent stools observed within the population of tested children.

(77) These data also show an improvement or even a standardization of the consistency of stools between D0 and D14 as illustrated by a reduction of the percentage of infants having hard, soft or liquid stools and an increase in the percentage of infants having formed stools. The infant milk according to the invention therefore allows restoring gut motility in infants, i.e., it is capable of re-establishing normal transit, preferably of the formed stools, for these patients when the latter is altered.

(78) The composition as a powder according to the invention does not alter, preserves, or even restores gut motility of the subject to which it is administered.

(79) The infant milk according to the invention is therefore effective as an anti-regurgitation and/or anti-reflux milk, both as regards the frequency of the regurgitations and/or reflux and as regards their intensity, and without altering gut motility, typically avoiding that the infants be subject to the inconveniences associated with an alteration of transit such as constipation, soft stools, liquid and/or too frequent stools (diarrhea), and/or colic, or even restoring gut motility of said infants.