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A specific synbiotic-containing amino acid-based formula in dietary management of cow's milk allergy: a randomized controlled trial
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2019 (English)In: Clinical and Translational Allergy, ISSN 2045-7022, E-ISSN 2045-7022, Vol. 9, article id 5Article in journal (Refereed) Published
Abstract [en]

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 coccoidesgroup (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.

Place, publisher, year, edition, pages
BioMed Central, 2019. Vol. 9, article id 5
Keywords [en]
Bifidobacterium breve M-16V, Gut microbiota, Prebiotic, Probiotic, Cow's milk allergy, Symptoms
National Category
Gastroenterology and Hepatology
Identifiers
URN: urn:nbn:se:umu:diva-155758DOI: 10.1186/s13601-019-0241-3ISI: 000455597600001PubMedID: 30651972OAI: oai:DiVA.org:umu-155758DiVA, id: diva2:1283170
Available from: 2019-01-28 Created: 2019-01-28 Last updated: 2019-09-05Bibliographically approved

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West, Christina E.

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