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- Title
Dietary supplementation with Bifidobacterium longum subsp. infantis (B. infantis) in healthy breastfed infants: study protocol for a randomised controlled trial.
- Authors
Awasthi, Smita; Wilken, Reason; Patel, Forum; German, J. Bruce; Mills, David A.; Lebrilla, Carlito B.; Kyoungmi Kim; Freeman, Samara L.; Smilowitz, Jennifer T.; Armstrong, April W.; Maverakis, Emanual; Kim, Kyoungmi
- Abstract
<bold>Background: </bold>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.<bold>Methods/design: </bold>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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>Clinicaltrials.gov # NCT02286999 , date of trial registration 23 October 2014.
- Subjects
CALIFORNIA; DIETARY supplements; BIFIDOBACTERIUM longum; RANDOMIZED controlled trials; PROBIOTICS; PHARMACOLOGY; GUT microbiome; THERAPEUTIC use of probiotics; AGE distribution; BREASTFEEDING; CLINICAL trials; COMPARATIVE studies; EXPERIMENTAL design; FECES; RESEARCH methodology; MEDICAL cooperation; RESEARCH protocols; RESEARCH; RESEARCH funding; TIME; EVALUATION research; TREATMENT effectiveness; BLIND experiment
- Publication
Trials, 2016, Vol 17, p1
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-016-1467-1