Treatment of Microscopic Colitis

Original Study ID : SLV 01-07035

NCT ID : NCT00184171

Brief Title : Treatment of Microscopic Colitis

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

Brief Summary :

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

Source : Norwegian University of Science and Technology

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 lymphcocytic colitis).

Overall Status : Completed

Start Date : November 2001

End Date : September 2007

Completion Date : September 2007

Official Title : Phase 4

Phase : Interventional

Study Design : Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Enrollment : 168

Verification Date : February 2008

First Received Date : September 10, 2005

Trial Eligibility

Criteria :
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

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : St. Olavs Hospital

City : Trondheim

Zip Code : 7006

Country : Norway

Facility Name : Rikshopitalet

City : Oslo

Zip Code : 7006

Country : Norway

Facility Name : Aker sykehus

City : Oslo

Zip Code : 7006

Country : Norway

Facility Name : Sykehuset Innlandet HF, Gjøvik

City : Gjovik

Zip Code : 2819

Country : Norway

Facility Name : Akershus Universitetssykehus

City : Nordbyhagen

Zip Code : 2819

Country : Norway

Facility Name : Sykehuset Innlandet, HF, Hamar

City : Hamar

Zip Code : 2819

Country : Norway

Facility Name : Sykehuset Innlandet HF, Lillehammer

City : Lillehammer

Zip Code : 2819

Country : Norway

Facility Name : Helse NordMøre og Romsdal

City : Molde

Zip Code : 2819

Country : Norway

Facility Name : Aust-Agder Sentralsjukehus

City : Arendal

Zip Code : 2819

Country : Norway

OutComes

Primary OutComes

Measure : Symptoms: Stool frequency and consistency

Secondary OutComes

Measure : Histological findins in biopsies from colon

Interventions

Type : Drug

Name : Budesonide

Type : Drug

Name : Bismuth

Type : Drug

Name : Fiber

Clinical Trial Name - Treatment of Microscopic Colitis