Pilot study to assess mucosa-associated microflora changes induced by defined formula diet and other therapies in inflammatory bowel diseases

ISRCTN	ISRCTN44563171
DOI	https://doi.org/10.1186/ISRCTN44563171
Secondary identifying numbers	N0016165995

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 30/01/2015

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Tanya Gilliver
Scientific

Department of Nutrition and Dietetics
Hammersmith
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Pilot study to assess mucosa-associated microflora changes induced by defined formula diet and other therapies in inflammatory bowel diseases
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Infliximab, fructan-oligofructose
Primary outcome measure	Changes in gut microflora before and after treatment
Secondary outcome measures	Not provided at time of registration
Overall study start date	30/06/2005
Completion date	30/06/2008
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	30 patients with Crohn's disease and 10 with ulcerative colitis
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	30/06/2005
Date of final enrolment	30/06/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Hammersmith Hospital

London
W12 0HS
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Hammersmith Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan