Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomised controlled trial of soluble plantain fibre for maintenance of health during periods of remission in Crohn's disease
Acronym
Study hypothesis
That supplementation of the normal diet with a preparation containing high molecular weight forms of soluble plantain fibre may be effective in maintaining disease-free periods in people diagnosed with Crohn's disease. Laboratory studies using a simulated intestinal microbiota have shown that a substantial proportion of these high molecular weight forms are likely to survive passage through the human intestine.
Ethics approval
Not provided at time of registration – submission pending
Study design
Double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Crohn's disease
Intervention
Patients will receive either:
1. Soluble plantain fibre
2. Placebo
The supplements will be provided to subjects in individual sachets containing 5 g soluble plantain fibre which represents half the daily dosage. The placebo will be identical to the test supplement in appearance, volume and taste but will contain additional maltodextrin instead of soluble plantain fibre.
Patients will be required to consume two sachets per day. Supplies will be prescribed at three monthly intervals for 12 months.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Relapse of Crohn's disease, defined as an increase in CDAI more than 100 above baseline or the initiation of corticosteroids or an anti-metabolite (azathioprine, 6-mercaptopurine or methotrexate), or infliximab or any of these in combination for the treatment of symptoms of Crohn's disease.
Secondary outcome measures
1. Time to first relapse (days)
2. Relapse, defined as a rise in CDAI more than 150
3. Rise in serum C-Reactive Protein (CRP) concentration of 10 g/l above baseline
4. Deterioration in quality of life score, as measured by disease-specific Health Related Quality of Life (HRQoL) instrument (the UK version of the Inflammatory Bowel Disease Questionnaire) and by a multi-attribute generic measure of utility (EuroQol [EQ5D] questionnaire)
5. Deterioration in patient's global assessment of disease activity as determined by visual analogue scores
6. The need for hospitalisation and/or surgery
7. The direct medical costs from the perspective of the UK National Health Service (NHS)
8. Acceptability of supplement in terms of palatability as determined by visual-analogue scores
9. Impact on faecal constituents, to include measuring transient or permanent alterations in bacterial populations, changes in short chain fatty acid production, and changes in faecal water toxicity
Overall trial start date
15/01/2007
Overall trial end date
15/07/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with Crohn's disease as diagnosed by conventional clinical, radiological and histological criteria
2. Crohn's disease involving small bowel, colon or both
3. Crohn's disease that is in remission: Crohn's Disease Activity Index (CDAI) less than 150
4. Patients who have had a relapse of disease within the previous 12 months (Harvey Bradshaw Index modified for retrospective use more than four)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
64
Participant exclusion criteria
1. Patients under 16 or unable to give informed consent
2. Patients who have had surgery for Crohn's disease within the previous 12 months
3. Any change to medication for Crohn's disease within the previous three months
4. Patients receiving corticosteroids or infliximab within the previous three months
5. CDAI more than 150
6. Patients currently receiving enteral nutrition as part of their treatment for Crohn's disease
7. Participation in other trials in the last three months
Recruitment start date
15/01/2007
Recruitment end date
15/07/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Liverpool
Liverpool
L69 3BX
United Kingdom
Sponsor information
Organisation
Provexis plc (UK)
Sponsor details
20 Mortlake High Street
London
SW14 8JN
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Provexis plc (UK)
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
Basic results (scientific)
Publication list