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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.

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



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).


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.


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.


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.


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

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