A Randomized and Placebo-Controlled Double-Blind Multicentre Study to Determine the Efficacy and Safety of VSL#3 Probiotic Food Supplement Mixture in Prevention of Endoscopic Recurrence in Crohn's Disease Patients With Ileocolonic Surgical Resection and Small Intestine to Colon Anastomosis.

University of Alberta16 sites in 1 country120 target enrollmentDecember 2003

ConditionsCrohn's Disease Inflammatory Bowel Disease

DrugsProbiotic - VSL#3

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Crohn's Disease
Sponsor: University of Alberta
Enrollment: 120
Locations: 16
Primary Endpoint: Prevention of severe endoscopic recurrence of Crohn's disease.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This randomized placebo-controlled double-blind, multi-centre trial will determine the efficacy of the probiotic VSL#3 in the prevention of Crohn's disease development following surgical resection and re-anastomosis. A total of 120 patients will be randomly assigned in a 1:1 ratio to receive VSL#3 or placebo for 90 days. Patients who respond to study treatment, as defined by the absence of a severe endoscopic recurrence at day 90, will be offered open-label VSL#3 for an additional 9 months.

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

TBD

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Alberta

Eligibility Criteria

Inclusion Criteria

•Subjects 16 years of age or older
•Diagnosis of Crohn's disease
•Resection of ileocolonic Crohn's disease and small bowel to colonic anastomosis within 30 days of randomization
•Able to provide informed written consent
•Women of child-bearing potential with a negative serum pregnancy test, and/or use of effective contraception