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
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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie budesonide's efficacy in treating lymphocytic colitis?
How does budesonide compare to standard-of-care corticosteroids in lymphocytic colitis treatment outcomes?
Which biomarkers predict response to budesonide in NCT00180050's lymphocytic colitis cohort?
What are the systemic adverse events of budesonide for microscopic colitis and mitigation strategies?
Are there combination therapies or alternative drugs to budesonide in the lymphocytic colitis therapeutic landscape?
Trial Locations
- Locations (1)
Medical Department I, Technical University Hospital
🇩🇪Dresden, Germany
Medical Department I, Technical University Hospital🇩🇪Dresden, Germany