Format

Send to

Choose Destination
Clin Transl Allergy. 2019 Jan 15;9:5. doi: 10.1186/s13601-019-0241-3. eCollection 2019.

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

Author information

1
1Guy's and St Thomas' Hospitals NHS Foundation Trust, London, UK.
2
Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Uppsalalaan 12, 3584 CT Utrecht, The Netherlands.
3
3Wageningen University, Wageningen, The Netherlands.
4
4Royal Alexandra Children's Hospital, Brighton, UK.
5
5University Hospital Verona, Verona, Italy.
6
6UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
7
Great Ormond Street, London, UK.
8
8Umeå University, Umeå, Sweden.
9
9Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
10
10Great North Children's Hospital, Newcastle upon Tyne, UK.

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.

KEYWORDS:

Bifidobacterium breve M-16V; Cow’s milk allergy; Gut microbiota; Prebiotic; Probiotic; Symptoms

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center