Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0016165995
Study information
Scientific title
Pilot study to assess mucosa-associated microflora changes induced by defined formula diet and other therapies in inflammatory bowel diseases
Acronym
Study hypothesis
It is now well established that the gut microflora plays a key role in the cause and / or sustaining of inflammation in Crohn's disease and ulcerative colitis. The main objective of this study is to identify (quantify and qualify) any changes in the gut microflora caused by various treatments, especially defined formula diets.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Digestive System: Crohn's disease
Intervention
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.
Updated 30/01/2015: the trial was stopped in September 2007 due to recruitment difficulties.
Intervention type
Drug
Phase
Not Applicable
Drug names
Infliximab, fructan-oligofructose
Primary outcome measures
Changes in gut microflora before and after treatment
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/06/2005
Overall trial end date
30/06/2008
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
30 patients with Crohn's disease and 10 with ulcerative colitis
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
30/06/2005
Recruitment end date
30/06/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hammersmith Hospital
London
W12 0HS
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hammersmith Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary