Title |
Dietary supplementation with Bifidobacterium longum subsp. infantis (B. infantis) in healthy breastfed infants: study protocol for a randomised controlled trial
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Published in |
Trials, July 2016
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DOI | 10.1186/s13063-016-1467-1 |
Pubmed ID | |
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 |
Abstract |
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. 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. 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. Clinicaltrials.gov # NCT02286999 , date of trial registration 23 October 2014. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United Kingdom | 1 | 11% |
Puerto Rico | 1 | 11% |
United States | 1 | 11% |
Canada | 1 | 11% |
Unknown | 5 | 56% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 5 | 56% |
Scientists | 3 | 33% |
Practitioners (doctors, other healthcare professionals) | 1 | 11% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 1 | <1% |
Italy | 1 | <1% |
Unknown | 169 | 99% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 24 | 14% |
Student > Bachelor | 24 | 14% |
Other | 13 | 8% |
Researcher | 13 | 8% |
Unspecified | 8 | 5% |
Other | 27 | 16% |
Unknown | 62 | 36% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 28 | 16% |
Nursing and Health Professions | 20 | 12% |
Biochemistry, Genetics and Molecular Biology | 14 | 8% |
Agricultural and Biological Sciences | 13 | 8% |
Immunology and Microbiology | 8 | 5% |
Other | 20 | 12% |
Unknown | 68 | 40% |