Budesonide for Induction of Remission in Incomplete Microscopic Colitis

Randomised, Double-blind, Placebo-controlled, Multi-centre Trial on the Efficacy and Safety of Budesonide for Induction of Remission in Incomplete Microscopic Colitis

The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.

Inclusion Criteria:

• Histologically established diagnosis of incomplete microscopic colitis (MCi)
• History of chronic non-bloody, watery diarrhoea
• Clinically active disease

Exclusion Criteria:

• Other significant abnormalities in colonoscopy
• Infectious cause of diarrhoea
• Clinical suspicion of drug-induced diarrhoea
• Prior and present MC
• History of bowel resection
• Radiation therapy of the abdominal or pelvic region
• Positive antibody titres for celiac disease
• Untreated active thyroid dysfunction
• Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder reducing life expectancy
• Abnormal hepatic function
• Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured
• History of colorectal cancer
• History of cancer (other than colorectal) in the last 5 years
• Therapy with immunomodulators/budesonide or other steroids/antibiotics/anti-diarrhoeal drugs
• Current or intended pregnancy or breast-feeding
• Doubt about the patient's cooperation, e.g. because of addiction to alcohol or drugs
• Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial