E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Substudy 1: Biopsy study v1_22 October 2007. The main objective is to test the hypothesis that soluble plantain fibre prevents adherence of biopsy-associated E. coli. The biopsy study will involve patients undergoing two additional flexible sigmoidoscopies at each of which four small (≤5mm) mucosal biopsies will be taken using standard diagnostic endoscopic forceps. Biopsies will be taken once before the study commences, at 3 months after the start of the trial and for patients who relapse, an additional set of biopsies will be taken at the time of withdrawal. Biopsies will be studied for the presence of tissue-associated E. coli using a bacterial culture system (the gentamicin protection assay). Bacterial DNA will also be extracted from biopy tissue and will be used to to quantify and characterise the biopsy-associated microbiota. The biopsy study will be offered to patients on a voluntary basis. The primary objective of the biopsy study is the quantification of biopsy-associated E. coli. We are also interested to determine the impact of the plantain fibre on the biopsy-associated microbiota. |
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E.3 | Principal 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). |
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E.4 | Principal exclusion criteria |
(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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |