Randomised controlled trial of soluble plantain fibre for maintenance of health during periods of remission in Crohn's disease v2

INTERVENTION: Product Name: Plantain NSP Product Code: NSP001 Pharmaceutical Form: Powder for oral solution Pharmaceutical form of the placebo: Powder for oral solution Route of administration of the placebo: Oral use CONDITION: Crohn's Disease ; MedDRA version: 13.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 ‐ Gastrointestinal disorders PRIMARY OUTCOME: Main Objective: To examine the efficacy of the soluble plantain fibre, incorporated into an FSMP prototype and given as a supplement to the normal diet. We are principally concerned with the ability of soluble plantain fibre to maintain health during remission in Crohn’s disease patients. This will be determined using the Crohn’s disease activity index (CDAI) with an increase of 100 points above baseline levels indicating that the patient has relapsed. Relapse of Crohn’s disease, defined as an increase in CDAI >100 above baseline or the initiation of corticosteroids or an anti‐metabolite (azathioprine, 6‐mercaptopurine or methotrexate), or infliximab or adilumimab or enteral nutrition or any of these in combination for the treatment of symptoms of Crohn’s disease. Primary end point(s): Relapse of Crohn’s disease, defined as an increase in CDAI >100 above baseline or the initiation of corticosteroids or an anti‐metabolite (azathioprine, 6‐mercaptopurine or methotrexate), or infliximab or adalimumab or enteral nutrition or any of these in combination for the treatment of symptoms of Crohn’s disease. Secondary Objective: Time to first relapse (days) Relapse, defined as a rise in CDAI>150 Rise in serum CRP concentration of 10mg/l above baseline Deterioration in quality of life score, as measured by disease‐specific HRQoL instrument (the UK version of the Inflammatory Bowel Disease Questionnaire) and by a multi‐attribute generic measure of utility (EuroQol, EQ5D) Deterioration in patient’s global assessment of disease activity as determined by visual analogue scores The need for hospitalization and/or surgery The direct medical costs from the perspective of the UK NHS Acceptability of supplement as determined by visual‐analogue scores 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 INCLUSION CRITERIA: (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