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

ISRCTN	ISRCTN81965907
DOI	https://doi.org/10.1186/ISRCTN81965907
Secondary identifying numbers	N0544122068

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 28/04/2015

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr John O Hunter
Scientific

Box No 262
Department of Gastroenterology
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)1223 217469
Email	john.hunter@addenbrookes.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	The value of faecal calprotectin (CPT) in monitoring the response to treatment of patients with inflammatory bowel disease
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	17/01/2003
Completion date	16/01/2006
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	80
Key inclusion criteria	80 patients
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	17/01/2003
Date of final enrolment	16/01/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Addenbrooke's NHS Trust

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Cambridge Consortium - Addenbrooke's (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