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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00175292

Enrollment

120

Registered

2005-09-15

Start date

2003-12-31

Completion date

Unknown

Last updated

2008-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Inflammatory Bowel Disease

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.

Interventions

DRUGProbiotic - VSL#3

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Prevention of severe endoscopic recurrence of Crohn's disease.	—

Secondary

Measure	Time frame
Endoscopic recurrence at 90 days and 360 days	—
Crohn's Disease Activity Index (CDAI)	—
Quality of life	—
Safety and tolerance of VSL#3	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026