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COMPLETEDPhase 3NCT00175292

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

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...

Lead sponsor: University of Alberta•17 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Alberta

Collaborators

Canadian Institutes of Health Research (CIHR)

Age

16 - No limit years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 14, 2008Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment120

Start dateDec 2003

Last updatedMay 14, 2008

Condition

Crohn's Disease Inflammatory Bowel Disease

Locations shown

Health Sciences Centre

Calgary, Alberta

Royal Alexandra Hospital

Edmonton, Alberta

Walter Mackenzie Health Sciences Centre

Edmonton, Alberta

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2008Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions