CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
Probioticbiological
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/NCT00971711
NCT00971711Phase 1Completed
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Phase I, Open Label Safety Study of VSL#3 in Adults With Irritable Bowel Syndrome

Baylor College of Medicine·interventional·Posted Sep 4, 2009·Updated Mar 8, 2016

In Brief

A Phase 1 clinical trial evaluating Probiotic for Irritable Bowel Syndrome. Completed, enrolled 21 participants across 2 sites.

Detailed Summary

Determine the safety and preliminary effectiveness of VSL#3 in adults with IBS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome
CountriesUnited States
CollaboratorsNational Institute of Nursing Research (NINR), University of Washington

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 4, 2009
Enrollment StartSep 1, 2009
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.8 years ago

Interventions

Probioticbiological

The subjects will be randomized into either a 4 week or 8 week treatment period with the probiotic. The treatment will be open label. They will take 2 packets once daily.