CompletedPhase 3

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

Canada120 participantsStarted 2003-12

Plain-language 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.

Who can participate

Age range16 Years

SexALL

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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

What they're measuring

Prevention of severe endoscopic recurrence of Crohn's disease.

Trial details

NCT IDNCT00175292

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

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