CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 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/NCT02124122
NCT02124122Phase 1Completed
CompareCT.gov

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

Tulane University School of Medicine·interventional·Posted Apr 28, 2014·Updated Apr 24, 2017

In Brief

A Phase 1 clinical trial evaluating Lactobacillus reuteri and Placebo for Healthy. Completed, enrolled 60 participants across 1 site.

Detailed 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.

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
2014201520162017201820192020202120222023202420252026
First PostedApr 28, 2014
Enrollment StartMar 1, 2015
Primary CompletionNov 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.2 years ago

Interventions

Lactobacillus reuteribiological

Probiotic

Placebobiological

Placebo