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Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

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

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

Published in: Trials | Issue 1/2016

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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.
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Metadata
Title
Dietary supplementation with Bifidobacterium longum subsp. infantis (B. infantis) in healthy breastfed infants: study protocol for a randomised controlled trial
Authors
Smita Awasthi
Reason Wilken
Forum Patel
J. Bruce German
David A. Mills
Carlito B. Lebrilla
Kyoungmi Kim
Samara L. Freeman
Jennifer T. Smilowitz
April W. Armstrong
Emanual Maverakis
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1467-1

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