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- Title
A specific synbiotic-containing amino acid-based formula in dietary management of cow's milk allergy: a randomized controlled trial.
- Authors
Fox, Adam T.; Wopereis, Harm; Van Ampting, Marleen T. J.; Oude Nijhuis, Manon M.; Butt, Assad M.; Peroni, Diego G.; Vandenplas, Yvan; Candy, David C. A.; Shah, Neil; West, Christina E.; Garssen, Johan; Harthoorn, Lucien F.; Knol, Jan; Michaelis, Louise J.
- 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
- Subjects
AMINO acids; MILK allergy; INFANT formulas
- Publication
Clinical & Translational Allergy, 2019, Vol 9, Issue 1, pN.PAG
- ISSN
2045-7022
- Publication type
Article
- DOI
10.1186/s13601-019-0241-3