A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.

Phase 3

Completed

• Conditions: Crohn's Disease; Inflammatory Bowel Disease

• Registration Number: NCT00175292
• Lead Sponsor: University of Alberta

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-12
• Last Update Posted: 2008-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

1. Use of perioperative steroids in tapering doses and anti-diarrheal agents
2. Treatment with a TNF-antagonist in the 8 weeks prior to resection
3. Clinically significant Crohn's disease elsewhere in the GI tract
4. Clinically documented short bowel syndrome
5. Serious disease other than Crohn's disease
6. Impaired liver or renal function
7. History of cancer with less than 2 years disease-free state
8. Abnormal Laboratory values
9. Alcohol or drug abuse
10. Some psychiatric conditions
11. Patients using other study medications
12. Patients who are unable to attend study visits or comply with study procedures
13. Positive pregnancy test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prevention of severe endoscopic recurrence of Crohn's disease.

Secondary Outcome Measures

Name	Time	Method
Endoscopic recurrence at 90 days and 360 days
Crohn's Disease Activity Index (CDAI)
Quality of life
Safety and tolerance of VSL#3

Trial Locations

Locations (16)

McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada

Hopital Maisonneuve-Rosemont; 🇨🇦 Montreal, Quebec, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada

Hopital St-Sacrement; 🇨🇦 Quebec City, Quebec, Canada

Hospitalier de l'Universite de Montreal; 🇨🇦 Montreal, Quebec, Canada

Hotel-Dieu Hospital; 🇨🇦 Kingston, Ontario, Canada

Surrey GI Clinic; 🇨🇦 Guelph, Ontario, Canada

Ottawa Hospital - Civic Campus; 🇨🇦 Ottawa, Ontario, Canada

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

Walter Mackenzie Health Sciences Centre; 🇨🇦 Edmonton, Alberta, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Dr. D.M. Petrunia, Inc.; 🇨🇦 Victoria, British Columbia, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Queen Elizabeth II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada