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Trials. 2016 Jul 22;17(1):340. doi: 10.1186/s13063-016-1467-1.

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

Author information

1
Department of Dermatology, University of California Davis Medical Center, Sacramento, CA, USA.
2
Department of Food Science & Technology, University of California Davis , Davis, CA, USA.
3
Department of Chemistry, University of California Davis , Davis, CA, USA.
4
Division of Biostatistics, Department of Public Health Sciences, University of California Davis , Davis, CA, USA.
5
Foods for Health Institute, University of California Davis , Davis, CA, USA.
6
Department of Dermatology, Keck School of Medicine at the University of Southern California, Los Angeles, CA, USA.
7
Department of Dermatology, University of California Davis Medical Center, Sacramento, CA, USA. emaverakis@ucdavis.edu.

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

PMID:
27449926
PMCID:
PMC4957407
DOI:
10.1186/s13063-016-1467-1
[Indexed for MEDLINE]
Free PMC Article

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