CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
Lactobacillus reuteri 17938 +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/NCT02460575
NCT02460575Phase 1Completed
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L. Reuteri for Pediatric Diarrhea in Peru: Growth, Enteropathy, and Microbiota

Tulane University School of Medicine·interventional·Posted Jun 2, 2015·Updated May 4, 2020

In Brief

A Phase 1 clinical trial evaluating Lactobacillus reuteri 17938 and Placebo for Healthy. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Phase I double blinded randomized trial of the safety and tolerability of Lactobacillus reuteri DSM 17938 given for five successive days in healthy children. Sixty children will receive study product at a treatment to placebo ratio of 2:1 and followed for 3 months for safety outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesPeru
CollaboratorsJohns Hopkins Bloomberg School of Public Health, Asociacion Benefica Prisma, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Virginia

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2, 2015
Enrollment StartJan 9, 2019
Primary CompletionDec 29, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 11.1 years ago

Interventions

Lactobacillus reuteri 17938biological

probiotic

Placebobiological

Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops.