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Safety of Lactobacillus Reuteri in Healthy Volunteers

NCT00774163 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-12-19

Study results available
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Summary

This is a phase one study to assess the safety of daily dosing of Lactobacillus reuteri in healthy adults in Peru. It is conducted as a preliminary study in support of a clinical trial to assess safety and efficacy of Lactobacillus reuteri versus placebo for treatment of pediatric diarrhea in Peru.

Conditions

  • Healthy

Interventions

BIOLOGICAL

Lactobacillus reuteri

Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period

OTHER

Placebo

5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Johns Hopkins Bloomberg School of Public Health

    collaborator OTHER

  • Asociacion Benefica Prisma

    collaborator OTHER

  • Tulane University School of Medicine

    lead 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
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-06-30
Completion
2010-10-31

Countries

  • Peru

Study Locations

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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 NCT00774163 on ClinicalTrials.gov