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Background  The development of probiotics as therapies to cure or prevent disease lags far behind that of other investigational medications. Rigorously designed phase I clinical trials are nearly non-existent in the field of probiotic research, which is a contributing factor to this disparity. As a consequence, how to appropriately dose probiotics to study their efficacy is unknown. Herein we propose a novel phase I ascending dose trial of  Bifidobacterium longum subsp. infantis  ( B. infantis ) to identify the dose required to produce predominant gut colonisation in healthy breastfed infants at 6 weeks of age.    Methods/design  This is a parallel-group, placebo-controlled, randomised, double-blind ascending dose phase I clinical trial of dietary supplementation with  B. infantis  in healthy breastfed infants. The objective is to determine the pharmacologically effective dose (ED) of  B. infantis  required to produce predominant (>50 %) gut colonisation in breastfed infants at 6 weeks of age. Successively enrolled infant groups will be randomised to receive two doses of either  B. infantis  or placebo on days 7 and 14 of life. Stool samples will be used to characterise the gut microbiota at increasing doses of  B. infantis .    Discussion  Probiotic supplementation has shown promising results for the treatment of a variety of ailments, but evidence-based dosing regimes are currently lacking. The ultimate goal of this trial is to establish a recommended starting dose of  B. infantis  for further efficacy-testing phase II trials designed to evaluate  B. infantis  for the prevention of atopic dermatitis and food allergies in at-risk children.    Trial registration  Clinicaltrials.gov # NCT02286999 , date of trial registration 23 October 2014.

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Dietary supplementation with Bifidobacterium longum subsp. infantis (B. infantis) in healthy breastfed infants: study protocol for a randomised controlled trial