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Safety and Efficacy of Probiotics in Bangladeshi Infants

Healthy Clinical Trial

Official title:
Safety and Efficacy of Probiotics in Bangladeshi Infants

Clinical Trial Summary

Here the investigators propose to preliminarily investigate the safety and effects of probiotics in infants in Bangladesh through a pilot randomized clinical trial. The investigators hypothesize that two probiotics are safe for infants in Bangladesh and may have an effect on biomarkers of gut health and immunity. The specific aims of this pilot are: i) to confirm the safety of administering probiotic strains to infants in low-income countries, ii) to determine the effects of dosing frequency on colonization and persistence of probiotics in the GI tract, iii) to measure markers of intestinal and immune function and microbiota structure.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01899378
Study type Interventional
Source Stanford University
Contact
Status Completed
Phase Phase 1
Start date October 2013
Completion date July 2014
View Details
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