CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 45 enrolled
Drug / intervention
Lactobacillus reuteri +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00774163
NCT00774163Phase 1Completed
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Phase 1: Safety of Lactobacillus Reuteri in Healthy Volunteers

Tulane University School of Medicine·interventional·Posted Oct 17, 2008·Updated Dec 19, 2016

In Brief

A Phase 1 clinical trial evaluating Lactobacillus reuteri and Placebo for Healthy. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesPeru
CollaboratorsNational Center for Complementary and Integrative Health (NCCIH), Johns Hopkins Bloomberg School of Public Health, Asociacion Benefica Prisma

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2008
Enrollment StartFeb 1, 2010
Primary CompletionJun 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.7 years ago

Interventions

Lactobacillus reuteribiological

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

Placeboother

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