Budesonide for Maintenance Treatment of Collagenous Colitis

Technische Universität Dresden75 enrolled

Overview

The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Collagenous Colitis

Interventions

BudesonideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * collagenous colitis * diarrhea * written informed consent Exclusion Criteria: * infectious causes for diarrhea * other inflammatory bowel diseases * history of colonic surgery * celiac disease * malignancies * severe concomitant diseases * use of budesonide, steroids, mesalazine within the previous 2 weeks * known intolerance to budesonide * history of lack of response to budesonide * pregnancy,lactation * drug and/or alcohol abuse * lack of compliance

Locations (1)

Medical Department I, Technical University Hospital

Dresden, Germany

Outcomes

Primary Outcomes

Proportion of patients in clinical remission after 6 months

Secondary Outcomes

time to relapse

safety

quality of life

histological improvement

Data from ClinicalTrials.gov

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