A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00175292
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 14, 2008
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of Alberta

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Inflammatory Bowel Disease Drug: Probiotic - VSL#3 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : December 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Prevention of severe endoscopic recurrence of Crohn's disease.

Secondary Outcome Measures :
  1. Endoscopic recurrence at 90 days and 360 days
  2. Crohn's Disease Activity Index (CDAI)
  3. Quality of life
  4. Safety and tolerance of VSL#3

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects 16 years of age or older
  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:

  1. Use of perioperative steroids in tapering doses and anti-diarrheal agents
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00175292

Canada, Alberta
Health Sciences Centre
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada
Dr. D.M. Petrunia, Inc.
Victoria, British Columbia, Canada
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
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
Canada, Quebec
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Hopital St-Sacrement
Quebec City, Quebec, Canada
Sponsors and Collaborators
University of Alberta
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Richard Fedorak, MD University of Alberta

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00175292     History of Changes
Other Study ID Numbers: VSL-FED-01
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 14, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes