Trial Details

Not Recruiting
Basic Information
Clinical ID c3355
Identifier ISRCTN44563171
Trial Title None
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Digestive System: Crohn's disease Digestive System Crohn's disease
Interventions This is an open, randomised study to assess the qualitative and quantitative changes of the mucosa-associated flora in patients with Crohn's disease on different treatments for their active disease. Patients will be recruited voluntarily, with informed consent from in patients on the wards and out patient clinics. Treatment with elemental diet is a primary therapy in Crohn's disease and leads to mucosal healing during treatment. Steroid treatment induces remission but does not have the same effect on mucosal healing. Infliximab treatment is well known to induce mucosal healing rapidly and with a high rate of efficacy. Therefore we have chosen Infliximab treated patients as our control group, to determine the changes in microflora that might occur as a consequence of mucosal healing alone. This will serve as a comparator to the flora changes due to elemental diet therapy. Patients will be assigned to treatment with Infliximab through normal clinical management decisions and these patients will act as the control group. Patient who would normally be treated with elemental diet will then be randomised to either elemental diet treatment (EO28 commercially available product from SHS) or elemental diet treatment plus 12g fructan-oligofructose.
Participant Information
Sponsor Record Provided by the NHSTCT Register - 2006 Update - Department of Health
City -
Country/Region United Kingdom
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -