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 |
| Protocol serial number | N0544122068 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrooke's (UK) |
- 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
Scientific
Box No 262
Department of Gastroenterology
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 217469 |
|---|---|
| john.hunter@addenbrookes.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 sample size at registration | 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
- United Kingdom
- England
Study participating centre
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
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 |
