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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic - VSL#3 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of severe endoscopic recurrence of Crohn's disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic recurrence at 90 days and 360 days | ||
| Crohn's Disease Activity Index (CDAI) | ||
| Quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Fedorak, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Centre | Calgary | Alberta | Canada | |||
| Royal Alexandra Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25460016 | Derived | 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. |
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| Safety and tolerance of VSL#3 |
| 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 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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