Randomised controlled trial of soluble plantain fibre for maintenance of health during periods of remission in Crohn's disease

ISRCTN	ISRCTN62819212
DOI	https://doi.org/10.1186/ISRCTN62819212
Protocol serial number	N/A
Sponsor	Provexis plc (UK)
Funder	Provexis plc (UK)

Submission date: 30/10/2006
Registration date: 03/01/2007
Last edited: 10/07/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jonathan Rhodes
Scientific

Department of Medicine
University of Liverpool
Liverpool
L69 3BX
United Kingdom

Study information

Primary study design	Interventional
Study design	Double-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised controlled trial of soluble plantain fibre for maintenance of health during periods of remission in Crohn's disease
Study objectives	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(s)	Not provided at time of registration – submission pending
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	15/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	64
Key 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)
Key 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
Date of first enrolment	15/01/2007
Date of final enrolment	15/07/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Liverpool

Liverpool
L69 3BX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/07/2017: No publications found, verifying study status with principal investigator.