Randomised controlled trial of soluble plantain fibre for maintenance of health during periods of remission in Crohn's disease v2 - Plantain NSP in Crohn's disease
- Conditions
- Crohn's DiseaseMedDRA version: 13.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
- Registration Number
- EUCTR2006-005526-23-GB
- Lead Sponsor
- Provexis Plc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 76
(i) Patients with Crohn’s disease as diagnosed by conventional clinical, radiological and histological criteria. (ii) Crohn’s disease involving small bowel, colon or both. (iii) Crohn’s disease that is in remission: Crohn’s Disease Activity Index (CDAI) < 150 (iv) Patients who have had a relapse of disease within the previous 12 months (Harvey Bradshaw Index modified for retrospective use).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
(i) Patients under 18 or unable to give informed consent. (ii) Patients who have had surgery for Crohn’s disease within the previous 12 months. (iii) Any change to medication for Crohn’s disease within the previous 3 months. (iv) Patients receiving corticosteroids or infliximab or anti-TNFs within the previous 3 months. (v) CDAI >150 (viii) Patients currently receiving enteral nutrition as part of their treatment for Crohn’s disease. (viii) Participation in other trials in the last 3 months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method