Crohn's DiseasePhase 3NCT00175292
A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.
A Phase 3 study testing Probiotic - VSL#3 in people with Crohn's Disease and Inflammatory Bowel Disease, run by University of Alberta at 17 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Crohn's Disease, Inflammatory Bowel Disease
- What is being tested?
- Probiotic - VSL#3
- How many people
- 120 participants
- Where
- 17 sitesCanada
- Study dates
- Dec 2003to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Canada17 sites
Health Sciences Centre
Calgary, Alberta
Royal Alexandra Hospital
Edmonton, Alberta
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta
Surrey GI Clinic
Guelph, Ontario
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia
McMaster University Medical Centre
Hamilton, Ontario
Hotel-Dieu Hospital
Kingston, Ontario
London Health Sciences Centre
London, Ontario
Hopital Maisonneuve-Rosemont
Montreal, Quebec
Hospitalier de l'Universite de Montreal
Montreal, Quebec
Royal Victoria Hospital
Montreal, Quebec
Ottawa Hospital - Civic Campus
Ottawa, Ontario
Hopital St-Sacrement
Québec, Quebec
Mount Sinai Hospital
Toronto, Ontario
St. Paul's Hospital
Vancouver, British Columbia
Dr. D.M. Petrunia, Inc.
Victoria, British Columbia
Health Sciences Centre
Winnipeg, Manitoba
About this study
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.
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.
- Conditions
- Crohn's Disease, Inflammatory Bowel Disease
- Being tested
- Probiotic - VSL#3
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic - VSL#3Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of severe endoscopic recurrence of Crohn's disease.
Secondary outcomes (4)
Endoscopic recurrence at 90 days and 360 days
Crohn's Disease Activity Index (CDAI)
Quality of life
Safety and tolerance of VSL#3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Richard Fedorak, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175292
- Sponsor's protocol ID
- VSL-FED-01
- Status last verified
- May 2008
- First submitted
- 13 Sep 2005
- Last updated
- 14 May 2008
- Results posted
- No
Publications
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.
PubMed 25460016
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00175292
- Acronym / sponsor ID
- VSL-FED-01
- Conditions
- Crohn's Disease, Inflammatory Bowel Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Dec 2003
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic - VSL#3 | Drug | – |
Primary outcome
Prevention of severe endoscopic recurrence of Crohn's disease.
4 secondary outcomes
Endoscopic recurrence at 90 days and 360 days
Crohn's Disease Activity Index (CDAI)
Quality of life
Safety and tolerance of VSL#3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2008.
- Derived from this study: PubMed 25460016Fedorak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Fedorak, MD principal investigator
University of Alberta
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotic - VSL#3 in people with Crohn's Disease and Inflammatory Bowel Disease, run by University of Alberta at 17 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of severe endoscopic recurrence of Crohn's disease.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00175292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2008.