Budesonide Treatment for Lymphocytic Colitis
Phase 3
Completed
- Conditions
- Microscopic Colitis
- Registration Number
- NCT00180050
- Lead Sponsor
- Technische Universität Dresden
- Brief Summary
The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis
- Detailed Description
The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- lymphocytic colitis
- diarrhea
- effective contraception
- written informed consent
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Exclusion Criteria
- other forms if IBD
- celiac disease
- infectious colitis
- history of colonic surgery
- use of budesonide, 5-ASA, steroids within th previous 4 weeks
- pregnancy, lactation
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of patients in clinical remission after 6 weeks
- Secondary Outcome Measures
Name Time Method safety quality of life histological improvement
Trial Locations
- Locations (1)
Medical Department I, Technical University Hospital
🇩🇪Dresden, Germany