CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 971 enrolled
Drug / intervention
LGG +1 moredrug
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/NCT01773967
NCT01773967Phase 3Completed
CompareCT.gov

Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis

Washington University School of Medicine·interventional·Posted Jan 23, 2013·Updated Sep 6, 2019

In Brief

A Phase 3 clinical trial evaluating LGG and micro-crystalline cellulose for Gastroenteritis. Completed, enrolled 971 participants across 10 sites.

Detailed Summary

The investigators will study the efficacy and side effect profile of LGG, a probiotic, in pediatric patients with acute gastroenteritis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroenteritis
CountriesUnited States
CollaboratorsColumbia University, Northwestern University, University of New Mexico, Children's National Research Institute, University of Utah, Wayne State University, Children's Hospital Medical Center, Cincinnati, University of Michigan, Brown University, University of California, Davis

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 23, 2013
Enrollment StartJul 1, 2014
Primary CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 13.4 years ago

Interventions

LGGdrug

LGG 10\^10 cfu PO BID X 5 days

micro-crystalline cellulosedrug

1 capsule PO bid x 5 days