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Safety and Efficacy of Probiotics in Bangladeshi Infants

NCT01899378 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2016-10-17

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Lactobacillus reuteri DSM 17938

10\^8 CFU

DIETARY_SUPPLEMENT

Bifidobacterium longum infantis

10\^9 CFU

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • Thrasher Research Fund

    collaborator OTHER

  • Stanford University

    lead OTHER

Principal Investigators

  • Yana Emmy E Hoy-Schulz, PhD · Stanford University

  • Julie Parsonnet, MD · Stanford University

  • Stephen Luby, MD · Stanford University

  • Leanne Unicomb, PhD · International Center for Diarrheal Disease Research, Bangladesh

  • Kaniz Jannat, MBBS · International Center for Diarrheal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Bangladesh

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01899378 on ClinicalTrials.gov