CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 38 enrolled
Drug / intervention
VSL#3 +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/NCT00114465
NCT00114465Phase 4Completed
CompareCT.gov

Randomized, Double-Blind, Placebo-Controlled Study of VSL#3 Versus Placebo in the Maintenance of Remission in Crohn's Disease

Orphan Australia·interventional·Posted Jun 15, 2005·Updated Sep 18, 2009

In Brief

A Phase 4 clinical trial evaluating VSL#3 and Placebo for Crohn's Disease. Completed, enrolled 38 participants across 1 site.

Detailed Summary

The primary objective of the study is to compare the efficacy of the probiotic VSL#3 versus placebo, in addition to standard maintenance drugs, in maintaining remission in Crohn's disease (CD). The secondary objectives are: * To determine the time till flare of CD patients on VSL#3 compared to placebo. * To assess whether concurrent therapy with VSL#3 leads to an improvement in the quality of life (QOL). * To assess whether concurrent therapy with VSL#3 reduces the severity of a flare if it occurs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustralia
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 15, 2005
Enrollment StartJun 1, 2005
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 21.0 years ago

Interventions

VSL#3drug

VSL#3 1 sachet twice a day

Placeboother

Placebo 1 sachel twice a day