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Clinical and Translational Allergy
Published in: Clinical and Translational Allergy 1/2019

Open Access 01-12-2019 | Clostridium | Research

A specific synbiotic-containing amino acid-based formula in dietary management of cow’s milk allergy: a randomized controlled trial

Authors: Adam T. Fox, Harm Wopereis, Marleen T. J. Van Ampting, Manon M. Oude Nijhuis, Assad M. Butt, Diego G. Peroni, Yvan Vandenplas, David C. A. Candy, Neil Shah, Christina E. West, Johan Garssen, Lucien F. Harthoorn, Jan Knol, Louise J. Michaelis, ASSIGN study group

Published in: Clinical and Translational Allergy | Issue 1/2019

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Abstract

Background

Here we report follow-up data from a double-blind, randomized, controlled multicenter trial, which investigated fecal microbiota changes with a new amino acid-based formula (AAF) including synbiotics in infants with non-immunoglobulin E (IgE)-mediated cow’s milk allergy (CMA).

Methods

Subjects were randomized to receive test product (AAF including fructo-oligosaccharides and Bifidobacterium breve M-16V) or control product (AAF) for 8 weeks, after which infants could continue study product until 26 weeks. Fecal percentages of bifidobacteria and Eubacterium rectale/Clostridium coccoides group (ER/CC) were assessed at 0, 8, 12, and 26 weeks. Additional endpoints included stool markers of gut immune status, clinical symptoms, and safety assessments including adverse events and medication use.

Results

The trial included 35 test subjects, 36 controls, and 51 in the healthy reference group. Study product was continued by 86% and 92% of test and control subjects between week 8–12, and by 71% and 80%, respectively until week 26. At week 26 median percentages of bifidobacteria were significantly higher in test than control [47.0% vs. 11.8% (p < 0.001)], whereas percentages of ER/CC were significantly lower [(13.7% vs. 23.6% (p = 0.003)]. Safety parameters were similar between groups. Interestingly use of dermatological medication and reported ear infections were lower in test versus control, p = 0.019 and 0.011, respectively. Baseline clinical symptoms and stool markers were mild (but persistent) and low, respectively. Symptoms reduced towards lowest score in both groups.

Conclusion

Beneficial effects of this AAF including specific synbiotics on microbiota composition were observed over 26 weeks, and shown suitable for dietary management of infants with non-IgE-mediated CMA.
Trial Registration NTR3979
Appendix
Available only for authorised users
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Metadata
Title
A specific synbiotic-containing amino acid-based formula in dietary management of cow’s milk allergy: a randomized controlled trial
Authors
Adam T. Fox
Harm Wopereis
Marleen T. J. Van Ampting
Manon M. Oude Nijhuis
Assad M. Butt
Diego G. Peroni
Yvan Vandenplas
David C. A. Candy
Neil Shah
Christina E. West
Johan Garssen
Lucien F. Harthoorn
Jan Knol
Louise J. Michaelis
ASSIGN study group
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Clinical and Translational Allergy / Issue 1/2019
Electronic ISSN: 2045-7022
DOI
https://doi.org/10.1186/s13601-019-0241-3

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