Dietary Microparticles in the Aetiology and Treatment of Crohn's Disease
| ISRCTN | ISRCTN64631737 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64631737 |
| Secondary identifying numbers | REC00114 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 08/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Miranda Lomer
Scientific
Scientific
St Thomas' Hospital
Nutrition and Dietetic Department
St Thomas' Hospital
London
SE1 7EH
United Kingdom
| Phone | +44 020 7928 9292 Extn 2342 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Does the removal of modern Western inorganic microparticles from the diet of patients with Crohn's disease improve their symptoms? The aims of the project are: 1. To characterise the undegradeable inorganic microparticulate matter of the modern Western diet 2. To compare the nutrient and microparticle intake in Crohn's disease versus controls 3. To undertake a multi-centre dietary intervention study of microparticle exclusion in Crohn's disease |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Digestive system diseases: Inflammatory bowel disease |
| Intervention | Not provided at time of registration |
| Intervention type | Other |
| Primary outcome measure | 1. Changes in Crohn's disease activity using the Harvey Bradshaw index (HBI) and the CDAI at four weekly appointments with the clinician and research nurse 2. Changes in use of medication will also be investigated. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 31/12/1998 |
| Completion date | 31/12/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 100 |
| Key inclusion criteria | Crohn's disease patients, cohabiting fit family members, non-Crohn's disease patients and age/sex matched controls (n=50/group) will be interviewed from the gastrointestinal clinics and staff at St Thomas' hospital. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 31/12/1998 |
| Date of final enrolment | 31/12/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive London (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2005 | Yes | No |
