Condition category
Digestive System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
30/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Tanya Gilliver

ORCID ID

Contact details

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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes