Status:
COMPLETED
A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Crohn's Disease
Inflammatory Bowel Disease
Eligibility:
All Genders
16+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00175292
Start Date
December 1 2003
Last Update
May 14 2008
Active Locations (17)
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1
Health Sciences Centre
Calgary, Alberta, Canada
2
Royal Alexandra Hospital
Edmonton, Alberta, Canada
3
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
4
St. Paul's Hospital
Vancouver, British Columbia, Canada