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Clinical Trial
. 2016 Jul 18:16:96.
doi: 10.1186/s12887-016-0637-3.

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

Christophe Dupont  1 , Elena Bradatan  2 , Pascale Soulaines  3 , Rita Nocerino  4 , Roberto Berni-Canani  4
Affiliations
Clinical Trial

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

Christophe Dupont et al. BMC Pediatr. .

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).

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Figures

Fig. 1
Fig. 1
Study flow chart. N: number of subjects
See this image and copyright information in PMC

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