Dietary Microparticles in the Aetiology and Treatment of Crohn's Disease
| ISRCTN | ISRCTN64631737 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64631737 |
| Protocol serial number | REC00114 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive London (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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 |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
SE1 7EH
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? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2005 | Yes | No |
