Overview

Clarithromycin in Active Crohn's Disease

Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
0
Participant gender:
All
Summary
Clarithromycin may be an effective therapy in Crohn's disease. It is a broad spectrum antibiotic. Crohn's disease, the investigators think, is in some way related to bacteria, which reside in the bowel. Previous studies of different types of antibiotic in Crohn's disease have shown encouraging results. Clarithromycin alters the bacteria in the bowel and gets into cells in the bowel which may contain bacteria. There is some evidence that clarithromycin can stimulate the immune system and improve the function of cells involved in killing bacteria in the bowel.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Royal Liverpool University Hospital
Collaborator:
Abbott
Treatments:
Clarithromycin
Criteria
Inclusion Criteria:

- Patients with Crohn's disease diagnosed by conventional clinical, radiological and
histological criteria.

- Active Crohn's disease: Crohn's Disease Activity Index (CDAI)> 200 and CRP > 10 mg/l.

- Patients on 10mg or less of prednisolone or 3mg budesonide.

- Patients on a stable dose of azathioprine for at least 3 months and on stable dose of
5-ASA preparation for at least one month.

Exclusion Criteria:

- Patients under 18 or unable to give informed consent.

- Patients on long term antibiotics for Crohn's disease or other indications

- Known sensitivity to clarithromycin

- Pregnant, post partum (<3months) or breast feeding females.

- Any change to medication for Crohn's disease for previous month.

- Patients with complications requiring surgery (significant intestinal obstruction,
perforation or abscess)

- CDAI > 450

- Participation in other trials in the last 3 months.

- Serious intercurrent infection or other clinically important active disease (including
renal and hepatic disease)

- Patients on cisapride, astemizole or terfenadine (prolonged QT interval and
arrhythmias reported with macrolide antibiotics)