Condition category
Digestive System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
08/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Miranda Lomer

ORCID ID

Contact details

St Thomas' Hospital
Nutrition and Dietetic Department
St Thomas' Hospital
London
SE1 7EH
United Kingdom
+44 020 7928 9292 Extn 2342

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15716665

Publication citations

  1. 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.

Additional files

Editorial Notes