Condition category
Digestive System
Date applied
30/10/2006
Date assigned
03/01/2007
Last edited
09/03/2015
Prospective/Retrospective
Prospectively 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

Prof Jonathan Rhodes

ORCID ID

Contact details

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

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 below to request a patient information sheet

Condition

Crohn's disease

Intervention

Patients will receive either:
1. Soluble plantain fibre, or
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

Phase

Not Applicable

Drug names

Soluble plantain fibre, maltodextrin

Primary outcome measures

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

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

http://www.provexis.com/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes