COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Treatment of Microscopic Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00184171
Recruitment Status : Terminated (insufficient data quality)
First Posted : September 16, 2005
Last Update Posted : January 21, 2015
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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

Condition or disease Intervention/treatment Phase
Colitis Drug: Budesonide Drug: Bismuth Drug: Fiber Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Microscopic Colitis (Collagenous Colitis and Lymphocytic Colitis) With Budesonide, Bismuth or Fiber
Study Start Date : November 2001
Actual Primary Completion Date : September 2010
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: Budesonide
Budesonide 9mg
Drug: Budesonide
Budesonide 9 mg

Experimental: bismuth
Bismuth mixture
Drug: Bismuth
Bismuth mixture

Sham Comparator: Fiber
Fiber preparation
Drug: Fiber
Fiber for control

Primary Outcome Measures :
  1. Symptoms: Stool frequency and consistency [ Time Frame: 2001 - 2011 ]
    September 2010: Patient's enrollment completed. Data analysis ongoing.

Secondary Outcome Measures :
  1. Histological findings in biopsies from colon [ Time Frame: 2001 - 2011 ]
    Patient's enrollment completed. Data analysis ongoing.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00184171

Layout table for location information
Aust-Agder Sentralsjukehus
Arendal, Norway
Sykehuset Innlandet HF, Gjøvik
Gjovik, Norway, 2819
Sykehuset Innlandet, HF, Hamar
Hamar, Norway
Sykehuset Innlandet HF, Lillehammer
Lillehammer, Norway
Helse NordMøre og Romsdal
Molde, Norway
Akershus Universitetssykehus
Nordbyhagen, Norway
Aker sykehus
Oslo, Norway
Oslo, Norway
St. Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Layout table for investigator information
Study Chair: Per G Farup, PhD Norwegian University of Science and Technology
Layout table for additonal information
Responsible Party: Norwegian University of Science and Technology Identifier: NCT00184171    
Other Study ID Numbers: SLV 01-07035
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Keywords provided by Norwegian University of Science and Technology:
Microscopic colitis
Drug treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis, Microscopic
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents