Treatment of Microscopic Colitis

Treatment of Microscopic Colitis (Collagenous Colitis and Lymphocytic Colitis) With Budesonide, Bismuth or Fiber

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00184171

Enrollment

105

Registered

2005-09-16

Start date

2001-11-30

Completion date

2014-10-31

Last updated

2015-01-21

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

Conditions

Colitis

Keywords

Microscopic colitis, Drug treatment, Diarrhoea

Brief summary

The study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic colitis

Detailed description

This randomized, controlled, open study compares the effects of 8 weeks' treatment with Budesonide, Bismuth and fiber on symptoms and histological findings in patients with microscopic colitis (both collagenous colitis and lymphocytic colitis).

Interventions

DRUGBudesonide

Budesonide 9 mg

DRUGBismuth

Bismuth mixture

DRUGFiber

Fiber for control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Microscopic colitis verified with biopsies from the colon * Symptoms to such an extent that treatment is indicated * Age \> 17 years * Informed consent

Exclusion criteria

* Previous treatment with any of the investigational drugs * Patients treated with ketoconazole * Pregnant and breast-feeding females

Design outcomes

Primary

Measure	Time frame	Description
Symptoms: Stool frequency and consistency	2001 - 2011	September 2010: Patient's enrollment completed. Data analysis ongoing.

Secondary

Measure	Time frame	Description
Histological findings in biopsies from colon	2001 - 2011	Patient's enrollment completed. Data analysis ongoing.

Countries

Norway

Outcome results

None listed

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