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Safety of Lactobacillus Reuteri in Healthy Children Ages 2 to 5 Years in Peru

NCT02124122 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-04-24

Study results available
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Summary

This is a Phase 1 study to assess the safety and tolerability of Lactobacillus reuteri (Lr) strain DSM 17938 in healthy children in Peru. It is a preliminary study in support of a clinical trial to assess safety and efficacy of L. reuteri for treatment of pediatric diarrhea in Peru.

Conditions

  • Healthy

Interventions

BIOLOGICAL

Lactobacillus reuteri

Probiotic

BIOLOGICAL

Placebo

Placebo

Sponsors & Collaborators

  • Tulane University School of Medicine

    lead OTHER

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Johns Hopkins Bloomberg School of Public Health

    collaborator OTHER

  • Asociacion Benefica Prisma

    collaborator OTHER

Principal Investigators

  • Richard A Oberhelman, MD · Tulane School of Public Health and Tropical Medicine

  • Margaret N Kosek, MD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-11-30
Completion
2016-01-31

Countries

  • Peru

Study Locations

More Related Trials

Entities

Drugs

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 NCT02124122 on ClinicalTrials.gov