Treatment of Microscopic Colitis

Norwegian University of Science and Technology105 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Colitis

Interventions

BudesonideDRUG

Budesonide 9 mg

BismuthDRUG

Bismuth mixture

FiberDRUG

Fiber for control

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Aust-Agder Sentralsjukehus

Arendal, Norway

Sykehuset Innlandet HF, Gjøvik

Gjøvik, Norway

Sykehuset Innlandet, HF, Hamar

Hamar, Norway

Sykehuset Innlandet HF, Lillehammer

Lillehammer, Norway

Outcomes

Primary Outcomes

Symptoms: Stool frequency and consistency

September 2010: Patient's enrollment completed. Data analysis ongoing.

Time frame: 2001 - 2011

Secondary Outcomes

Histological findings in biopsies from colon

Patient's enrollment completed. Data analysis ongoing.

Time frame: 2001 - 2011

Data from ClinicalTrials.gov

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