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

September 13, 2005
September 15, 2005
May 14, 2008
December 2003
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Prevention of severe endoscopic recurrence of Crohn's disease.
Same as current
Complete list of historical versions of study NCT00175292 on Archive Site
  • Endoscopic recurrence at 90 days and 360 days
  • Crohn's Disease Activity Index (CDAI)
  • Quality of life
  • Safety and tolerance of VSL#3
Same as current
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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.
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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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • Crohn's Disease
  • Inflammatory Bowel Disease
Drug: Probiotic - VSL#3
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Fedorak RN, Feagan BG, Hotte N, Leddin D, Dieleman LA, Petrunia DM, Enns R, Bitton A, Chiba N, Paré 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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University of Alberta
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Richard Fedorak, MD University of Alberta
University of Alberta
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP