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 |
| Protocol serial number | N0016165995 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Hammersmith Hospital NHS Trust (UK) |
- 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
Scientific
Department of Nutrition and Dietetics
Hammersmith
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Infliximab, fructan-oligofructose |
| Primary outcome measure(s) |
Changes in gut microflora before and after treatment |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 sample size at registration | 40 |
| 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
- United Kingdom
- England
Study participating centre
Hammersmith Hospital
London
W12 0HS
United Kingdom
W12 0HS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
