Back to Search
Start Over
Dietary supplementation with Bifidobacterium longum subsp. infantis (B. infantis) in healthy breastfed infants: study protocol for a randomised controlled trial.
- Source :
-
Trials . 7/22/2016, Vol. 17, p1-11. 11p. 2 Charts, 1 Graph. - Publication Year :
- 2016
-
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. [ABSTRACT FROM AUTHOR]
- Subjects :
- *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
Subjects
Details
- Language :
- English
- ISSN :
- 17456215
- Volume :
- 17
- Database :
- Academic Search Index
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 117018457
- Full Text :
- https://doi.org/10.1186/s13063-016-1467-1