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

Crohn's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175292
• Other study ID #: VSL-FED-01
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: May 12, 2008
• Start date: December 2003

Study information

• Verified date: May 2008
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Intervention

Drug:
• Probiotic - VSL#3

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Calgary	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	Walter Mackenzie Health Sciences Centre	Edmonton	Alberta
Canada	Surrey GI Clinic	Guelph	Ontario
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	Hotel-Dieu Hospital	Kingston	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Hopital Maisonneuve-Rosemont	Montreal	Quebec
Canada	Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	Ottawa Hospital - Civic Campus	Ottawa	Ontario
Canada	Hopital St-Sacrement	Quebec City	Quebec
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Dr. D.M. Petrunia, Inc.	Victoria	British Columbia
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of severe endoscopic recurrence of Crohn's disease.
Secondary	Endoscopic recurrence at 90 days and 360 days
Secondary	Crohn's Disease Activity Index (CDAI)
Secondary	Quality of life
Secondary	Safety and tolerance of VSL#3