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

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Jonathan Rhodes


Contact details

Department of Medicine
University of Liverpool
L69 3BX
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Crohn's disease


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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Liverpool
L69 3BX
United Kingdom

Sponsor information


Provexis plc (UK)

Sponsor details

20 Mortlake High Street
SW14 8JN
United Kingdom

Sponsor type




Funder type


Funder name

Provexis plc (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes

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