Back to resultsA Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.
Primary Purpose
Crohn's Disease, Inflammatory Bowel Disease
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Probiotic - VSL#3
Sponsored by
About this trial
This is an interventional prevention trial for Crohn's Disease
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Health Sciences Centre
- Royal Alexandra Hospital
- Walter Mackenzie Health Sciences Centre
- St. Paul's Hospital
- Dr. D.M. Petrunia, Inc.
- Health Sciences Centre
- Queen Elizabeth II Health Sciences Centre
- Surrey GI Clinic
- McMaster University Medical Centre
- Hotel-Dieu Hospital
- London Health Sciences Centre
- Ottawa Hospital - Civic Campus
- Mount Sinai Hospital
- Hopital Maisonneuve-Rosemont
- Hospitalier de l'Universite de Montreal
- Royal Victoria Hospital
- Hopital St-Sacrement
Outcomes
Primary Outcome Measures
Prevention of severe endoscopic recurrence of Crohn's disease.
Secondary Outcome Measures
Endoscopic recurrence at 90 days and 360 days
Crohn's Disease Activity Index (CDAI)
Quality of life
Safety and tolerance of VSL#3
Full Information
NCT ID
NCT00175292
First Posted
September 13, 2005
Last Updated
May 12, 2008
Sponsor
University of Alberta
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT00175292
Brief Title
A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.
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 Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Alberta
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Inflammatory Bowel Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Probiotic - VSL#3
Primary Outcome Measure Information:
Title
Prevention of severe endoscopic recurrence of Crohn's disease.
Secondary Outcome Measure Information:
Title
Endoscopic recurrence at 90 days and 360 days
Title
Crohn's Disease Activity Index (CDAI)
Title
Quality of life
Title
Safety and tolerance of VSL#3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Fedorak, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Walter Mackenzie Health Sciences Centre
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Dr. D.M. Petrunia, Inc.
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Surrey GI Clinic
City
Guelph
State/Province
Ontario
Country
Canada
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Hotel-Dieu Hospital
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
Ottawa Hospital - Civic Campus
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hopital St-Sacrement
City
Quebec City
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25460016
Citation
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.
Results Reference
derived
Learn more about this trial
A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.
We'll reach out to this number within 24 hrs