Dietary supplementation with Bifidobacterium longum subsp. infantis (B. infantis) in healthy breastfed infants: study protocol for a randomised controlled trial
- 2016-07-22
- Trials 17(1)
- S. Awasthi
- R. Wilken
- F. Patel
- J. German
- D. Mills
- C. Lebrilla
- Kyoung-Youl Kim
- Samara L. Freeman
- J. Smilowitz
- A. Armstrong
- E. Maverakis
- PubMed: 27449926
- DOI: 10.1186/s13063-016-1467-1
Abstract
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.
Keywords: Atopic dermatitis; Atopy; Bifidobacterium infantis; Dose-escalation; Food allergy; Phase I clinical trial; Probiotic.
Research Insights
Supplement | Health Outcome | Effect Type | Effect Size |
---|---|---|---|
Bifidobacterium longum subsp. infantis | Predominant Gut Colonization | Beneficial | Large |
Bifidobacterium longum subsp. infantis M-63 | Preventative Gut Colonisation | Beneficial | Moderate |