A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.
A Randomized and Placebo-Controlled Double-Blind Multicentre Study to Determine the Efficacy and Safety of VSL#3 Probiotic Food Supplement Mixture in Prevention of Endoscopic Recurrence in Crohn's Disease Patients With Ileocolonic Surgical Resection and Small Intestine to Colon Anastomosis.
1 other identifier
interventional
120
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedMay 14, 2008
May 1, 2008
September 13, 2005
May 12, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Prevention of severe endoscopic recurrence of Crohn's disease.
Secondary Outcomes (4)
Endoscopic recurrence at 90 days and 360 days
Crohn's Disease Activity Index (CDAI)
Quality of life
Safety and tolerance of VSL#3
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
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
Related Publications (1)
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.
PMID: 25460016DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Fedorak, MD
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
December 1, 2003
Last Updated
May 14, 2008
Record last verified: 2008-05