A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.
NCT ID: NCT00175292
Last Updated: 2008-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2003-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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Probiotic - VSL#3
Eligibility Criteria
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Inclusion Criteria
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
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
16 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
University of Alberta
OTHER
Principal Investigators
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Richard Fedorak, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
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Health Sciences Centre
Calgary, Alberta, 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
Health Sciences Centre
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Surrey GI Clinic
Guelph, Ontario, Canada
McMaster University Medical Centre
Hamilton, Ontario, Canada
Hotel-Dieu Hospital
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Hopital St-Sacrement
Québec, Quebec, Canada
Countries
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References
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Fedorak RN, Feagan BG, Hotte N, Leddin D, Dieleman LA, Petrunia DM, Enns R, Bitton A, Chiba N, Pare P, Rostom A, Marshall J, Depew W, Bernstein CN, Panaccione R, Aumais G, Steinhart AH, Cockeram A, Bailey RJ, Gionchetti P, Wong C, Madsen K. The probiotic VSL#3 has anti-inflammatory effects and could reduce endoscopic recurrence after surgery for Crohn's disease. Clin Gastroenterol Hepatol. 2015 May;13(5):928-35.e2. doi: 10.1016/j.cgh.2014.10.031. Epub 2014 Nov 6.
Other Identifiers
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VSL-FED-01
Identifier Type: -
Identifier Source: org_study_id