Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REC00114
Study information
Scientific title
Acronym
Study hypothesis
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
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
Not Specified
Patient information sheet
Condition
Digestive system diseases: Inflammatory bowel disease
Intervention
Not provided at time of registration
Intervention type
Other
Phase
Not Specified
Drug names
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 trial start date
31/12/1998
Overall trial end date
31/12/2001
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
31/12/1998
Recruitment end date
31/12/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
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
Funders
Funder type
Government
Funder name
NHS Executive London (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
Basic results (scientific)
Publication list
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15716665
Publication citations
-
Results
Lomer MC, Grainger SL, Ede R, Catterall AP, Greenfield SM, Cowan RE, Vicary FR, Jenkins AP, Fidler H, Harvey RS, Ellis R, McNair A, Ainley CC, Thompson RP, Powell JJ, Lack of efficacy of a reduced microparticle diet in a multi-centred trial of patients with active Crohn's disease., Eur J Gastroenterol Hepatol, 2005, 17, 3, 377-384.