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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00175292
First received: September 13, 2005
Last updated: May 12, 2008
Last verified: May 2008

September 13, 2005
May 12, 2008
December 2003
Not Provided
Prevention of severe endoscopic recurrence of Crohn's disease.
Prevention of severe endoscopic recurrence of Crohn’s disease.
Complete list of historical versions of study NCT00175292 on ClinicalTrials.gov 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
  • Endoscopic recurrence at 90 days and 360 days
  • Crohn’s Disease Activity Index (CDAI)
  • Quality of life
  • Safety and tolerance of VSL#3
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Crohn's Disease
  • Inflammatory Bowel Disease
Drug: Probiotic - VSL#3
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
Not Provided
Not Provided

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00175292
VSL-FED-01
Not Provided
Not Provided
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