A Thickened Amino-acid Formula in Infants with Cow's Milk Allergy Failing to Respond to Protein Hydrolysate Formulas: a Randomized Double-blind Trial

Overview

Journal Paediatr Drugs

Specialties Pediatrics
Pharmacology

Date 2014 Dec 3

PMID 25446768

Citations 5

Authors

Christophe Dupont

Nicolas Kalach

Pascale Soulaines

Elena Bradatan

Alain Lachaux

Francois Payot

Frederic de Blay

Lydie Guenard-Bilbault

Riad Hatahet

Sandra Mulier

Affiliations

Soon will be listed here.

Abstract

Introduction: Amino-acid-based formulas (AAFs) are recommended for children with cow's milk protein allergy (CMPA) failing to respond to extensively hydrolyzed formulas (eHFs).

Objective: This study aimed to assess the tolerance/hypoallergenicity and efficacy of a thickened AAF (TAAF) in these infants.

Methods: This multicenter, double-blind, randomized controlled trial (NCT01940068) compared 3-month feeding with a pectin-based TAAF (Novalac(®), United Pharmaceuticals, Paris, France) and a commercially available "reference" AAF (RAAF; Neocate(®), Nutricia, Germany) in infants aged <18 months with CMPA and persistent allergy symptoms with eHF feeding. Reported here are the results of an interim analysis after 1 month of feeding.

Results: Of the 86 infants randomized, CMPA with eHF intolerance was confirmed in 75 infants; all of them tolerated the allocated AAFs. The major allergic symptom disappeared within 1 month in 61.9 and 51.5 % and regurgitations disappeared in 66.7 and 42.3 % of infants who received TAAF and RAAF, respectively. Infants had significantly more normal stools (soft or formed consistency) with the TAAF (90.5 vs. 66.7 %; p = 0.011). From baseline, daily family life significantly improved with both AAFs: crying time decreased by 97.3 (p < 0.001) and 28.6 min (p = 0.014) and sleeping time increased by 64.6 (p = 0.009) and 29.0 min with TAAF and RAAF, respectively. At day 30, weight and body mass index z-score gains were 0.1 and 0.2 with TAAF and 0.2 and 0.0 with RAAF.

Conclusion: Both AAFs were well tolerated by infants with CMPA and eHF intolerance and ensured appropriate growth, with the TAAF providing additional comfort.

Citing Articles

The use of amino acid formulas in pediatric patients with allergy to cow's milk proteins: Recommendations from a group of experts.

Ribes-Koninckx C, Amil-Dias J, Espin B, Molina M, Segarra O, Diaz-Martin J Front Pediatr. 2023; 11:1110380.

PMID: 37033186 PMC: 10073469. DOI: 10.3389/fped.2023.1110380.

Budget Impact of Early Introduction of Amino Acid Formula in Managing Infants with Cow Milk Protein Allergy: Arabian Gulf Countries' Experience.

Miqdady M, AlMutaeri S, Alsawi N, Goronfolah L, Tzivinikos C, Al Hameli H J Asthma Allergy. 2023; 16:73-82.

PMID: 36636707 PMC: 9831123. DOI: 10.2147/JAA.S390352.

Re-evaluation of pectin (E 440i) and amidated pectin (E 440ii) as food additives.

Mortensen A, Aguilar F, Crebelli R, Di Domenico A, Dusemund B, Frutos M EFSA J. 2020; 15(7):e04866.

PMID: 32625540 PMC: 7010145. DOI: 10.2903/j.efsa.2017.4866.

A well-tolerated new amino acid-based formula for cow's milk allergy.

Fierro V, Valluzzi R, Banzato C, Plaza M, Bosque M, Ibero M Immun Inflamm Dis. 2020; 8(2):140-149.

PMID: 32109005 PMC: 7212192. DOI: 10.1002/iid3.286.

Evaluation of an Amino Acid-Based Formula in Infants Not Responding to Extensively Hydrolyzed Protein Formula.

Vanderhoof J, Moore N, de Boissieu D J Pediatr Gastroenterol Nutr. 2016; 63(5):531-533.

PMID: 27526059 PMC: 5084628. DOI: 10.1097/MPG.0000000000001374.

References

Dupont C, Chouraqui J, De Boissieu D, Bocquet A, Bresson J, Briend A . Dietary treatment of cows' milk protein allergy in childhood: a commentary by the Committee on Nutrition of the French Society of Paediatrics. Br J Nutr. 2011; 107(3):325-38. DOI: 10.1017/S0007114511004831. View

Vandenplas Y, Koletzko S, Isolauri E, Hill D, Oranje A, Brueton M . Guidelines for the diagnosis and management of cow's milk protein allergy in infants. Arch Dis Child. 2007; 92(10):902-8. PMC: 2083222. DOI: 10.1136/adc.2006.110999. View

Britton J, Kastin A . Biologically active polypeptides in milk. Am J Med Sci. 1991; 301(2):124-32. DOI: 10.1097/00000441-199102000-00007. View

Kalach N, Kapel N, Waligora-Dupriet A, Castelain M, Cousin M, Sauvage C . Intestinal permeability and fecal eosinophil-derived neurotoxin are the best diagnosis tools for digestive non-IgE-mediated cow's milk allergy in toddlers. Clin Chem Lab Med. 2012; 51(2):351-61. DOI: 10.1515/cclm-2012-0083. View

Vandenplas Y, De Greef E . Extensive protein hydrolysate formula effectively reduces regurgitation in infants with positive and negative challenge tests for cow's milk allergy. Acta Paediatr. 2014; 103(6):e243-50. PMC: 4282102. DOI: 10.1111/apa.12615. View

Bindels J, Boerma J . Hydrolysed cow's milk formulae. Pediatr Allergy Immunol. 1994; 5(3):189-90. DOI: 10.1111/j.1399-3038.1994.tb00237.x. View

Sicherer S, Noone S, Koerner C, Christie L, Burks A, Sampson H . Hypoallergenicity and efficacy of an amino acid-based formula in children with cow's milk and multiple food hypersensitivities. J Pediatr. 2001; 138(5):688-93. DOI: 10.1067/mpd.2001.113007. View

Hill D, Heine R, Cameron D, Catto-Smith A, Chow C, Francis D . Role of food protein intolerance in infants with persistent distress attributed to reflux esophagitis. J Pediatr. 2000; 136(5):641-7. DOI: 10.1067/mpd.2000.104774. View

Hill D, Cameron D, Francis D, Hosking C . Challenge confirmation of late-onset reactions to extensively hydrolyzed formulas in infants with multiple food protein intolerance. J Allergy Clin Immunol. 1995; 96(3):386-94. DOI: 10.1016/s0091-6749(95)70058-7. View

10.

Berni Canani R, Nocerino R, Leone L, Di Costanzo M, Terrin G, Passariello A . Tolerance to a new free amino acid-based formula in children with IgE or non-IgE-mediated cow's milk allergy: a randomized controlled clinical trial. BMC Pediatr. 2013; 13:24. PMC: 3583738. DOI: 10.1186/1471-2431-13-24. View

11.

Meyer R, Venter C, Fox A, Shah N . Practical dietary management of protein energy malnutrition in young children with cow's milk protein allergy. Pediatr Allergy Immunol. 2012; 23(4):307-14. DOI: 10.1111/j.1399-3038.2012.01265.x. View

12.

Estep D, Kulczycki Jr A . Treatment of infant colic with amino acid-based infant formula: a preliminary study. Acta Paediatr. 2000; 89(1):22-7. DOI: 10.1080/080352500750029004. View

13.

Kemp A, Hill D, Allen K, Anderson K, Davidson G, Day A . Guidelines for the use of infant formulas to treat cows milk protein allergy: an Australian consensus panel opinion. Med J Aust. 2008; 188(2):109-12. DOI: 10.5694/j.1326-5377.2008.tb01534.x. View

14.

Harvey B, Langford J, Harthoorn L, Gillman S, Green T, Schwartz R . Effects on growth and tolerance and hypoallergenicity of an amino acid-based formula with synbiotics. Pediatr Res. 2013; 75(2):343-51. DOI: 10.1038/pr.2013.211. View

15.

Niggemann B, Binder C, Dupont C, Hadji S, Arvola T, Isolauri E . Prospective, controlled, multi-center study on the effect of an amino-acid-based formula in infants with cow's milk allergy/intolerance and atopic dermatitis. Pediatr Allergy Immunol. 2001; 12(2):78-82. DOI: 10.1034/j.1399-3038.2001.012002078.x. View

16.

Chung C, Yamini S, Trumbo P . FDA's health claim review: whey-protein partially hydrolyzed infant formula and atopic dermatitis. Pediatrics. 2012; 130(2):e408-14. DOI: 10.1542/peds.2012-0333. View

17.

Saylor J, Bahna S . Anaphylaxis to casein hydrolysate formula. J Pediatr. 1991; 118(1):71-4. DOI: 10.1016/s0022-3476(05)81848-7. View

18.

de Boissieu D, Dupont C . Allergy to extensively hydrolyzed cow's milk proteins in infants: safety and duration of amino acid-based formula. J Pediatr. 2002; 141(2):271-3. DOI: 10.1067/mpd.2002.126299. View

19.

Isolauri E, Sutas Y, Makinen-Kiljunen S, Oja S, Isosomppi R, Turjanmaa K . Efficacy and safety of hydrolyzed cow milk and amino acid-derived formulas in infants with cow milk allergy. J Pediatr. 1995; 127(4):550-7. DOI: 10.1016/s0022-3476(95)70111-7. View

20.

Makinen-Kiljunen S, Sorva R . Bovine beta-lactoglobulin levels in hydrolysed protein formulas for infant feeding. Clin Exp Allergy. 1993; 23(4):287-91. DOI: 10.1111/j.1365-2222.1993.tb00324.x. View