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Completed

NCT Number: NCT00175292

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 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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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Disease Inflammatory Bowel Diseases Intestinal Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Health Sciences Centre, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic - VSL#3

Drug

Primary outcomes

  1. Prevention of severe endoscopic recurrence of Crohn's disease.

Secondary outcomes

  1. Endoscopic recurrence at 90 days and 360 days

  2. Crohn's Disease Activity Index (CDAI)

  3. Quality of life

  4. Safety and tolerance of VSL#3

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study 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.

Important dates

Study start
2003
First posted
Sep 15, 2005
Registry last updated
May 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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