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

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

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


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.

Original languageEnglish
Article number5
Number of pages11
JournalClinical and Translational Allergy
Issue number5
Publication statusPublished - 15 Jan 2019


  • Bifidobacterium breve M-16V
  • Cow's milk allergy
  • Gut microbiota
  • Prebiotic
  • Probiotic
  • Symptoms


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