None listed
Conditions
Brief summary
An investigation of the effect of three antibiotics directed against Mycobacterium paratuberculosis, the cause of Johne's disease in sheep and cattle, in patients with active Crohn's disease
Interventions
Two year's treatment with rifabutin, clarithromycin and clofazamine.
Sponsors
Pfizer Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Crohn's disease diagnosed according to standard clinical, endoscopic, radiological and histological criteria were entered into the study. At entry, all had active disease, defined as Crohn's Disease Activity Index (CDAI) 200. Patients with isolated upper gastrointestinal or isolated perianal Crohn's disease or a stoma were not eligible for participation in the study. Patients requiring intravenous corticosteroids at the time of study entry and those thought likely to require surgery during the first four months of the study were also excluded. Other exclusion criteria included a stool examination positive for enteric pathogens, pathogenic ova or parasites, uncontrolled serious infection, and significant cardiovascular, respiratory, renal, hepatic, neurologic, psychiatric, endocrine or metabolic disease. Permitted medications included: corticosteroids at a dose of prednisone of 10 mg or less (or other steroids at an equivalent dosage) over the month prior to enrolment; azathioprine or 6-mercaptopurine at a stable dose for at least 6 months prior to enrolment and 5-aminosalicylates at a stable dose for at least four weeks prior to entry.
Exclusion criteria
The use of antibiotics for Crohn's disease within one month of entry was an exclusion criterion as were use of methotrexate, cyclosporine or drugs known to interact with rifabutin (e.g. anticoagulants) within three months of entry.
Outcome results
None listed