Treatment of Microscopic Colitis

Not Applicable

Terminated

• Conditions: Colitis
• Interventions: Drug: Bismuth; Drug: Fiber; Drug: Budesonide

• Registration Number: NCT00184171
• Lead Sponsor: Norwegian University of Science and Technology

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).

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-16
• Primary Completion: 2010-09
• Study Completion: 2014-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-20
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bismuth	Bismuth	Bismuth mixture
Fiber	Fiber	Fiber preparation
Budesonide	Budesonide	Budesonide 9mg

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Histological findings in biopsies from colon	2001 - 2011	Patient's enrollment completed. Data analysis ongoing.

Trial Locations

Locations (9)

Aker sykehus; 🇳🇴 Oslo, Norway

Helse NordMøre og Romsdal; 🇳🇴 Molde, Norway

Sykehuset Innlandet HF, Lillehammer; 🇳🇴 Lillehammer, Norway

Aust-Agder Sentralsjukehus; 🇳🇴 Arendal, Norway

Sykehuset Innlandet, HF, Hamar; 🇳🇴 Hamar, Norway

Rikshopitalet; 🇳🇴 Oslo, Norway

Sykehuset Innlandet HF, Gjøvik; 🇳🇴 Gjovik, Norway

Akershus Universitetssykehus; 🇳🇴 Nordbyhagen, Norway

St. Olavs Hospital; 🇳🇴 Trondheim, Norway