Tolerance and growth in children with cow's milk allergy fed a thickened extensively hydrolyzed casein-based formula

Christophe Dupont, Elena Bradatan, Pascale Soulaines, Rita Nocerino, Roberto Berni-Canani, Christophe Dupont, Elena Bradatan, Pascale Soulaines, Rita Nocerino, Roberto Berni-Canani

Abstract

Background: In case of cow's milk allergy (CMA), pediatric guidelines recommend for children the use of extensively hydrolyzed formulas (eHFs) as elimination diet. According to the American Academy of Pediatrics, the hypoallergenicity of each specific eHF should be tested in subjects with CMA.

Methods: A prospective, multicenter trial was performed to assess the tolerance/hypoallergenicity of a thickened casein-based eHF (eHCF, Allernova AR®, United Pharmaceuticals, France) in infants aged <12 months with CMA proven by a double-blind placebo-controlled food challenge. Its efficacy, measured through allergy symptoms monitoring and Cow's Milk-related Symptom Score (CoMiSS) calculation, and safety were evaluated during a 4-month feeding period. Growth z-scores were computed based on WHO anthropometric data.

Results: Thirty infants (mean age: 4.8 ± 3.0 months) with CMA proven by a DBPCFC tolerated the eHCF during the 4-month study. The CoMiSS, crying and regurgitation scores significantly decreased by 4.2 ± 4.0, 0.9 ±1.2 and 0.7 ± 1.1 respectively, after 14 days of feeding (p < 0.001). The Scoring Atopic Dermatitis index, of 33.2 ± 14.8 at inclusion in 9 patients, significantly decreased by 15.5 ± 6.7 and 21.1 ± 11.2, after 14 and 45 days of feeding, respectively (p < 0.001). The percentage of infants having normal stool consistency (soft or formed stools) significantly improved from 66.7 % (20/30) at inclusion to 90.0 % (27/30) after 14 days of feeding (p = 0.020). The growth z-scores, negative at study inclusion, significantly improved over the 4-month study. No adverse event was related to the eHCF.

Conclusion: The thickened eHCF was tolerated by more than 90 % of included allergic infants with 95 % confidence interval and can therefore be considered as hypoallergenic in accordance with current guidelines. The improvement of growth indices and absence of related adverse events confirmed its safety. Results of this trial back the use of the tested thickened eHCF as an efficient and safe alternative in children with CMA.

Trial registration: ClinicalTrials.gov, number NCT02351531 , registered on 27 January 2015.

Keywords: Cow’s Milk-related Symptom Score (CoMiSS); Cow’s milk allergy; Hypoallergenic extensively hydrolyzed casein-based formula; Infant growth; Scoring Atopic Dermatitis (SCORAD).

Figures

Fig. 1
Fig. 1
Study flow chart. N: number of subjects

References

    1. Johansson Bieber T, Dahl R, Friedmann PS, Lanier BQ, Lockey RF, et al. Revised nomenclature for allergy for global use: Report of the Nomenclature Review Committee of the World Allergy Organization, October 2003. J Allergy Clin Immunol. 2004;113:832–6. doi: 10.1016/j.jaci.2003.12.591.
    1. Nwaru BI, Hickstein L, Panesar SS, Roberts G, Muraro A, Sheikh A, et al. Prevalence of common food allergies in Europe: a systematic review and meta-analysis. Allergy. 2014;69:992–1007. doi: 10.1111/all.12423.
    1. Vandenplas Y, Koletzko S, Isolauri E, Hill D, Oranje AP, Brueton M, et al. Guidelines for the diagnosis and management of cow’s milk protein allergy in infants. Arch Dis Child. 2007;92:902–8. doi: 10.1136/adc.2006.110999.
    1. Koletzko S, Niggemann B, Arato A, Dias JA, Heuschkel R, Husby S, et al. European Society of Pediatric Gastroenterology, Hepatology, and Nutrition. Diagnostic approach and management of cow’s-milk protein allergy in infants and children: ESPGHAN GI Committee practical guidelines. J Pediatr Gastroenterol Nutr. 2012;55:221–9. doi: 10.1097/MPG.0b013e31825c9482.
    1. Luyt D, Ball H, Makwana N, Green MR, Bravin K, Nasser SM, et al. BSACI guideline for the diagnosis and management of cow’s milk allergy. Clin Exp Allergy. 2014;44:642–72. doi: 10.1111/cea.12302.
    1. Fiocchi A, Brozek J, Schünemann H, Bahna SL, von Berg A, Beyer K, et al. World Allergy Organization (WAO) Diagnosis and Rationale for Action against Cow’s Milk Allergy (DRACMA) Guidelines. Pediatr Allergy Immunol. 2010;21:1–125.
    1. Dupont C. Diagnosis of cow’s milk allergy in children: determining the gold standard? Expert Rev Clin Immunol. 2014;10:257–67. doi: 10.1586/1744666X.2014.874946.
    1. Dupont C, Chouraqui JP, de Boissieu D, Bocquet A, Bresson JL, Briend A, et al. 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. 2012;107:325–38. doi: 10.1017/S0007114511004831.
    1. Høst A, Koletzko B, Dreborg S, Muraro A, Wahn U, Aggett P, et al. Dietary products used in infants for treatment and prevention of food allergy. Joint Statement of the European Society for Paediatric Allergology and Clinical Immunology (ESPACI) Committee on Hypoallergenic Formulas and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee on Nutrition. Arch Dis Child. 1999;81:80–4. doi: 10.1136/adc.81.1.80.
    1. American Academy of Pediatrics Committee on Nutrition. Hypoallergenic infant formulas. Pediatrics. 2000;106:346–9. doi: 10.1542/peds.106.2.346.
    1. Giovannini M, D’Auria E, Caffarelli C, Verduci E, Barberi S, Indinnimeo L, et al. Nutritional management and follow up of infants and children with food allergy: Italian Society of Pediatric Nutrition/Italian Society of Pediatric Allergy and Immunology Task Force Position Statement. Ital J Pediatr. 2014;40:1. doi: 10.1186/1824-7288-40-1.
    1. Meyer R, Venter C, Fox AT, Shah N. Practical dietary management of protein energy malnutrition in young children with cow’s milk protein allergy. Pediatr Allergy Immunol. 2012;23:307–14. doi: 10.1111/j.1399-3038.2012.01265.x.
    1. Nelson SP, Chen EH, Syniar GM, Christoffel KK. Prevalence of symptoms of gastroesophageal reflux during infancy. A pediatric practice-based survey. Pediatric Practice Research Group. Arch Pediatr Adolesc Med. 1997;151(6):569–72. doi: 10.1001/archpedi.1997.02170430035007.
    1. Vandenplas Y, Dupont C, Eigenmann P, Host A, Kuitunen M, Ribes-Koninckx C. A workshop report on the development of the Cow’s Milk-related Symptom Score awareness tool for young children. Acta Paediatr. 2015;104:334–9. doi: 10.1111/apa.12902.
    1. Vandenplas Y, Hachimi-Idrissi S, Casteels A, Mahler T, Loeb H. A clinical trial with an “anti-regurgitation” formula. Eur J Pediatr. 1994;153:419–23.
    1. Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997;32:920–4. doi: 10.3109/00365529709011203.
    1. Consensus Report of the European Task Force on Atopic Dermatitis Severity scoring of atopic dermatitis: the SCORAD index. Dermatology. 1993;186:23–31. doi: 10.1159/000247298.
    1. WHO Multicentre Growth Reference Study Group . WHO Child Growth Standards: Length/height-for-age, weight-for-age, weight-for-length, weight-for-height and body mass index-for-age: Methods and development. Geneva: World Health Organization; 2006.
    1. Aggett P, Agostoni C, Axelsson I, Goulet O, Hernell O, Koletzko B, et al. Core data for nutrition trials in infants: a discussion document--a commentary by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2003;36:338–42. doi: 10.1097/00005176-200303000-00007.
    1. Koletzko B, Fewtrell M, Gibson R, van Goudoever JB, Hernell O, Shamir R, et al. Core data necessary for reporting clinical trials on nutrition in infancy. Ann Nutr Metab. 2015;66:31–5. doi: 10.1159/000365766.
    1. Vandenplas Y, Althera Study Group. Steenhout P, Grathwohl D. A pilot study on the application of a symptom-based score for the diagnosis of cow’s milk protein allergy. SAGE Open Medicine. 2014;2:2050312114523423. doi: 10.1177/2050312114523423.
    1. Vandenplas Y, De Greef E, Hauser B, Paradice Study Group An extensively hydrolysed rice protein-based formula in the management of infants with cow’s milk protein allergy: preliminary results after 1 month. Arch Dis Child. 2014;99:933–6. doi: 10.1136/archdischild-2013-304727.
    1. Vandenplas Y, De Greef E, ALLAR study group Extensive protein hydrolysate formula effectively reduces regurgitation in infants with positive and negative challenge tests for cow’s milk allergy. Acta Paediatr. 2014;103:e243–50. doi: 10.1111/apa.12615.
    1. 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;12:78–82. doi: 10.1034/j.1399-3038.2001.012002078.x.
    1. Niggemann B, von Berg A, Bollrath C, Berdel D, Schauer U, Rieger C, et al. Safety and efficacy of a new extensively hydrolyzed formula for infants with cow’s milk protein allergy. Pediatr Allergy Immunol. 2008;19:348–54. doi: 10.1111/j.1399-3038.2007.00653.x.
    1. Dupont C, Hol J, Nieuwenhuis EE. Cow’s Milk Allergy Modified by Elimination and Lactobacilli study group. An extensively hydrolysed casein-based formula for infants with cows’ milk protein allergy: tolerance/hypo-allergenicity and growth catch-up. Br J Nutr. 2015;113:1102–12. doi: 10.1017/S000711451500015X.
    1. Isolauri E, Sütas Y, Mäkinen-Kiljunen S, Oja SS, 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;127:550–7. doi: 10.1016/S0022-3476(95)70111-7.
    1. Isolauri E, Sütas Y, Salo MK, Isosomppi R, Kaila M. Elimination diet in cow’s milk allergy: risk for impaired growth in young children. J Pediatr. 1998;132:1004–9. doi: 10.1016/S0022-3476(98)70399-3.
    1. Agostoni C, Grandi F, Scaglioni S, Giannì ML, Torcoletti M, Radaelli G, et al. Growth pattern of breastfed and nonbreastfed infants with atopic dermatitis in the first year of life. Pediatrics. 2000;106:E73. doi: 10.1542/peds.106.5.e73.
    1. Venter C, Laitinen K, Vlieg-Boerstra B. Nutritional aspects in diagnosis and management of food hypersensitivity-the dietitians role. J Allergy (Cairo) 2012;2012:269376.
    1. Savino F, Castagno E, Monti G, Serraino P, Peltran A, Oggero R, et al. Z-score of weight for age of infants with atopic dermatitis and cow’s milk allergy fed with a rice-hydrolysate formula during the first two years of life. Acta Paediatr Suppl. 2005;94:115–9. doi: 10.1080/08035320510043664.
    1. Agostoni C, Fiocchi A, Riva E, Terracciano L, Sarratud T, Martelli A, et al. Growth of infants with IgE-mediated cow’s milk allergy fed different formulas in the complementary feeding period. Pediatr Allergy Immunol. 2007;18:599–606. doi: 10.1111/j.1399-3038.2007.00566.x.
    1. de Jong NW, Sprikkelman AB, Oude Elberink HN, Arends NJ, Vlieg-Boerstra BJ. Blinded sensory evaluation of extensively hydrolyzed formulas and amino acid formulas. Ann Allergy Asthma Immunol. 2014;113:235–6. doi: 10.1016/j.anai.2014.05.027.
    1. Miraglia Del Giudice M, D’Auria E, Peroni D, Palazzo S, Radaelli G, Comberiati P, et al. Flavor, relative palatability and components of cow’s milk hydrolysed formulas and amino acid-based formula. Ital J Pediatr. 2015;41:42. doi: 10.1186/s13052-015-0141-7.
    1. Medjad-Guillou N, Henocq A, Arnaud-Battandier F. [Does the hydrolysis of proteins change the acceptability and the digestive tolerance of milk for infants? The results of a comparative and randomized prospective study] Ann Pediatr (Paris) 1992;39:202–6.
    1. Schulz KF, Altman DG, Moher D, CONSORT Group CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8:18. doi: 10.1186/1741-7015-8-18.

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