At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 88 enrolled

Drug / intervention

Smectite +2 moredietary

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/NCT01657032

NCT01657032Phase 4Completed

Compare CT.gov

Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis: A Double Blind Randomized, Placebo- Controlled Trial

Medical University of Warsaw·interventional·Posted Aug 3, 2012·Updated Apr 1, 2014

In Brief

A Phase 4 clinical trial evaluating Smectite, Placebo, and 1 other intervention for Diarrhea. Completed, enrolled 88 participants across 1 site.

Detailed Summary

Treatment diarrhea with Lactobacillus GG or smectite has proven efficacy. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of both LGG and smectite in management of children with acute gastroenteritis (AGE).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDiarrhea

CountriesPoland

Collaborators--

Timeline

Phase 4CompletedFinished

2011201220132014201520162017201820192020202120222023202420252026

Enrollment StartAug 2010

First PostedAug 2012

Primary CompletionSep 2012

Study CompletionOct 2012

TodayJul 2026

First PostedAug 3, 2012

Enrollment StartAug 1, 2010

Primary CompletionSep 1, 2012

Study CompletionOct 1, 2012

TodayJul 2, 2026

Enrollment to primary: 2.1 yearsPosted 13.9 years ago

Interventions

Smectitedietary

Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.

Placebodietary

Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.

Lactobacillus GGdietary

All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite