Condition category
Digestive System
Date applied
18/11/2005
Date assigned
18/11/2005
Last edited
06/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Neil Fedorak

ORCID ID

Contact details

Director
Division of Gastroenterology
University of Alberta
Suite 205 College Plaza
8215 - 112 Street
Edmonton
T6G 2C8
Canada
+1 780 407 6941
richard.fedorak@ualberta.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00175292

Protocol/serial number

UCT-52194

Study information

Scientific title

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Crohn’s Disease/Inflammatory Bowel Disease

Intervention

A randomised controlled trial of VSL#3 versus placebo

Trial details received 12 Sept 2005

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

01/01/2002

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

120

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

01/01/2002

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Canada

Trial participating centre

Director
Edmonton
T6G 2C8
Canada

Sponsor information

Organisation

University of Alberta (Canada)

Sponsor details

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

Sponsor type

University/education

Website

http://www.ualberta.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: UCT-52194)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes