Budesonide Treatment for Lymphocytic Colitis

Phase 3CompletedNCT00180050

Technische Universität Dresden40 enrolled

Overview

The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Microscopic Colitis

Interventions

BudesonideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical Department I, Technical University Hospital

Dresden, Germany

Outcomes

Primary Outcomes

Proportion of patients in clinical remission after 6 weeks

Secondary Outcomes

safety

quality of life

histological improvement

Data from ClinicalTrials.gov

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