Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
28/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr John O Hunter

ORCID ID

Contact details

Box No 262
Department of Gastroenterology
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 217469
john.hunter@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544122068

Study information

Scientific title

The value of faecal calprotectin (CPT) in monitoring the response to treatment of patients with inflammatory bowel disease

Acronym

Study hypothesis

Do patients whose treatment, leading to symptomatic improvement, results in a fall of faecal calprotectin (CPT) to less than 250 µg/g have longer remissions than those whose CPT after treatment remains elevated?

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

Treatment

Patient information sheet

Condition

Inflammatory bowel disease

Intervention

Patients with active inflammatory bowel disease will be treated for 2 weeks according to the advice of their clinicians with either oral prednisolone 40 mg daily (ulcerative colitis or Crohn's) or enteral feeds (Crohn's disease only). Patients failing to respond clinically to the initial 2 weeks treatment will be excluded from the trial. Those who reach remission will provide a faecal specimen for analysis of CPT. If this is less than 250 µg/g they will proceed with standard continuing therapy, either tailing off the corticosteroids, or continuing with food reintroductions if on an enteral feed. Those whose CPT after 2 weeks treatment is still raised, despite clinical improvement, will be randomised either to follow corticosteroid reduction or food reintroduction as before, or alternatively to continue the original treatment of prednisolone 40 mg, or enteral feed, with weekly determinations of CPT until the CPT falls below 250 µg/g or 4 weeks have elapsed, whichever is the sooner. Patients will be followed up for 6 months with monthly determinations of faecal CPT; clinical relapse rates in those whose CPTs after the initial 2 weeks treatment were greater, or less, than 250 µg/g will be compared.

Updated 28/04/2015: the trial was stopped due to participant recruitment issues.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

17/01/2003

Overall trial end date

16/01/2006

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

80 patients

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

17/01/2003

Recruitment end date

16/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Cambridge Consortium - Addenbrooke's (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

Publication citations

Additional files

Editorial Notes