Condition category
Digestive System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Richard Neil Fedorak


Contact details

Division of Gastroenterology
University of Alberta
Suite 205 College Plaza
8215 - 112 Street
T6G 2C8

Additional identifiers

EudraCT number number


Protocol/serial number


Study information

Scientific title

A randomised controlled trial of VSL#3 for the prevention of endoscopic recurrence following surgery for Crohn's disease


Study hypothesis

To determine the efficacy of the probiotic VSL#3 in the prevention of Crohn’s disease development following surgical resection and re-anastomosis.

Ethics approval

The Health Research Ethics Board (Biomedical Panel) of the University of Alberta, Edmonton, Alberta, gave approval on the 22nd June 2001

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Crohn’s Disease/Inflammatory Bowel Disease


A randomised controlled trial of VSL#3 versus placebo

Trial details received 12 Sept 2005

Intervention type



Not Applicable

Drug names

Primary outcome measure

To assess the efficacy of VSL#3 for the prevention of severe endoscopic recurrence (Rutgeerts Grade three or four) of Crohn’s disease, within 90 days of study treatment, in patients who have undergone an ileocolonic resection with small intestine to colonic anastomosis

Secondary outcome measures

1. To assess the efficacy of VSL#3 to prevent all endoscopic recurrence of Crohn’s disease (Rutgeerts Grades one to four) within 90 days of study treatment
2. Determine the proportion of patients who require medical therapy for management of recurrent Crohn’s disease within 90 days of study treatment
3. To compare the time to severe endoscopic recurrence of Crohn’s disease (Rutgeerts endoscopic grade three or grade four) in subjects who receive immediate (within 30 days post resection) versus delayed (more than 90 days post resection) introduction of VSL#3 as maintenance therapy
4. To determine the proportion of patients who require medical therapy for management of their recurrent Crohn’s disease within 365 days of study treatment
5. To compare the treatments for overall Crohn’s disease activity as measured by the Crohn’s disease activity index (CDAI)
6. To compare the treatment for disease specific quality of life endpoints as measured by the inflammatory bowel disease questionnaire (IBDQ)
7. To assess the safety and tolerance of VSL#3
8. To determine:
8.1. The quantity and type of bacterial colonisation
8.2. Mucosal cytokine levels
8.3. Histologic injury
8.4. Mucosal metalloproteinase activity at the neo-terminal ileum and serum cytokine genotyping

These studies will be conducted at a subset of participating centres in Canada.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Subjects who are 16 years of age or older
2. Have a diagnosis of Crohn’s disease of at least three months’ duration, prior to ileocolonic resection, and the diagnosis is confirmed by radiological studies or endoscopy with biopsy or surgical pathology
3. Resection of ileocolonic Crohn’s disease, with margins macroscopically free of disease, and small bowel to colonic anastomosis no more than 30 days prior to randomisation
4. Females of child-bearing potential (have not had tubal ligation, hysterectomy or other surgical procedure for sterilisation) must have a negative urine or serum pregnancy test within one week of entry into the study and agree to use an acceptable method for contraception throughout the trial. Acceptable methods of contraception include oral contraceptives, implantable contraceptives, injectable contraceptives, intrauterine device or barrier methods (diaphragm with spermicidal gel plus condoms, condoms with contraceptive sponges, condom plus intravaginal suppository).
5. Voluntarily able to provide informed written consent

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Use of other medications for the treatment of Crohn’s disease following surgical resection (perioperative steroids in tapering doses and antidiarrhoeal agents - codeine, loperamide, diphenoxylate or cholestyramine are acceptable)
2. Treatment with a tumour necrotising factor (TNF)-antagonist in the eight weeks prior to resection
3. Clinically significant Crohn’s disease elsewhere in the gastrointestinal tract
4. Clinically documented short bowel syndrome (greater than 100 cm of small bowel resected)
5. Serious underlying disease other than Crohn’s disease
6. Significantly impaired liver or renal function
7. History of cancer with less than two years in a documented disease-free state (other than resected cutaneous basal and squamous cell carcinoma and or in situ cervical cancer)
8. Patients with the following laboratory abnormalities:
8.1. White blood count less than 3 x 10^9/l
8.2. Lymphocyte count less than 0.5 x 10^9/l
8.3. Haemoglobin less than 80 g/dl
8.4. Platelet count less than 125 x 10^9/l or more than 800 x 10^9/l
8.5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 2.0 times the upper limit of normal
8.6. Alkaline phosphatase more than 2.0 times the upper limit of normal
8.7. Serum Creatinine more than 1.5 times the upper limit of normal
9. Patients using ethanol or consuming illicit drugs which, in the investigators opinion, may interfere with compliance with the study procedures
10. Patients with active psychiatric problems, which, in the investigators opinion, may interfere with compliance with the study procedures
11. Patients using concomitant investigational therapy
12. Patients who are unable to attend study visits or comply with study procedures

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

T6G 2C8

Sponsor information


University of Alberta (Canada)

Sponsor details

1A University Campus N.W.
1-05 Assinaboia Hall
T6G 2E1

Sponsor type




Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (ref: UCT-52194)

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR, IRSC

Funding Body Type

government organisation

Funding Body Subtype

National government



Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2015 results in: (added 19/02/2019)

Publication citations

Additional files

Editorial Notes

11/04/2019: Internal review. 19/02/2019: Publication reference added. 21/01/2019: Contact details updated.