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

作者：Awasthi Smita; Wilken Reason; Patel Forum; German J Bruce; Mills David A; Lebrilla Carlito B; Kim Kyoungmi; Freeman Samara L; Smilowitz Jennifer T; Armstrong April W; Maverakis Emanual

来源：Trials, 2016, 17(1): 340.

DOI：10.1186/s13063-016-1467-1

• Bifidobacterium infantis
• Probiotic
• Atopy
• Dose-escalation
• Phase I clinical trial
• Atopic dermatitis
• Food allergy

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.

• 出版日期2016-7-22