Budesonide Treatment for Lymphocytic Colitis

Efficacy and Safety of Budesonide for Treatment of Lymphocytic Colitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00180050

Enrollment

Registered

2005-09-16

Start date

2002-01-31

Completion date

2007-08-31

Last updated

2010-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microscopic Colitis

Keywords

lymphocytic colitis, microscopic colitis, budesonide

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

Interventions

DRUGBudesonide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportion of patients in clinical remission after 6 weeks	—

Secondary

Measure	Time frame
safety	—
quality of life	—
histological improvement	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026