Treatment of Microscopic Colitis

This study has been terminated.
(insufficient data quality)
Information provided by (Responsible Party):
Norwegian University of Science and Technology Identifier:
First received: September 10, 2005
Last updated: January 20, 2015
Last verified: January 2015
The study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic colitis

Condition Intervention
Drug: Budesonide
Drug: Bismuth
Drug: Fiber

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Microscopic Colitis (Collagenous Colitis and Lymphocytic Colitis) With Budesonide, Bismuth or Fiber

Resource links provided by NLM:

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Symptoms: Stool frequency and consistency [ Time Frame: 2001 - 2011 ] [ Designated as safety issue: No ]
    September 2010: Patient's enrollment completed. Data analysis ongoing.

Secondary Outcome Measures:
  • Histological findings in biopsies from colon [ Time Frame: 2001 - 2011 ] [ Designated as safety issue: No ]
    Patient's enrollment completed. Data analysis ongoing.

Enrollment: 105
Study Start Date: November 2001
Study Completion Date: October 2014
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00184171

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
Study Chair: Per G Farup, PhD Norwegian University of Science and Technology
  More Information

Responsible Party: Norwegian University of Science and Technology Identifier: NCT00184171     History of Changes
Other Study ID Numbers: SLV 01-07035 
Study First Received: September 10, 2005
Last Updated: January 20, 2015
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Microscopic colitis
Drug treatment

Additional relevant MeSH terms:
Colitis, Microscopic
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents processed this record on May 26, 2016