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

Completed

Conditions: Crohn's disease
Digestive System
Noninfective enteritis and colitis

Registration Number: ISRCTN62819212

Lead Sponsor: Provexis plc (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 64

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)

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Time to first relapse (days) <br>2. Relapse, defined as a rise in CDAI more than 150<br>3. Rise in serum C-Reactive Protein (CRP) concentration of 10 g/l above baseline<br>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) <br>5. Deterioration in patient's global assessment of disease activity as determined by visual analogue scores<br>6. The need for hospitalisation and/or surgery<br>7. The direct medical costs from the perspective of the UK National Health Service (NHS)<br>8. Acceptability of supplement in terms of palatability as determined by visual-analogue scores<br>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