A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.
Crohn's Disease, Inflammatory Bowel Disease
About this trial
This is an interventional prevention trial for Crohn's Disease
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 Exclusion Criteria: Use of perioperative steroids in tapering doses and anti-diarrheal agents Treatment with a TNF-antagonist in the 8 weeks prior to resection Clinically significant Crohn's disease elsewhere in the GI tract Clinically documented short bowel syndrome Serious disease other than Crohn's disease Impaired liver or renal function History of cancer with less than 2 years disease-free state Abnormal Laboratory values Alcohol or drug abuse Some psychiatric conditions Patients using other study medications Patients who are unable to attend study visits or comply with study procedures Positive pregnancy test
Sites / Locations
- Health Sciences Centre
- Royal Alexandra Hospital
- Walter Mackenzie Health Sciences Centre
- St. Paul's Hospital
- Dr. D.M. Petrunia, Inc.
- Health Sciences Centre
- Queen Elizabeth II Health Sciences Centre
- Surrey GI Clinic
- McMaster University Medical Centre
- Hotel-Dieu Hospital
- London Health Sciences Centre
- Ottawa Hospital - Civic Campus
- Mount Sinai Hospital
- Hopital Maisonneuve-Rosemont
- Hospitalier de l'Universite de Montreal
- Royal Victoria Hospital
- Hopital St-Sacrement