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VSL#3 Versus Placebo in Maintenance of Remission in Crohn's Disease

NCT00114465 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2009-09-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

VSL#3

VSL#3 1 sachet twice a day

OTHER

Placebo

Placebo 1 sachel twice a day

Sponsors & Collaborators

  • Orphan Australia

    lead OTHER

Principal Investigators

  • Ian C Lawrance, MD PhD · School of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00114465 on ClinicalTrials.gov