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Treatment of Microscopic Colitis

N

Norwegian University of Science and Technology

Status

Terminated

Conditions

Colitis

Treatments

Drug: Fiber
Drug: Bismuth
Drug: Budesonide

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00184171
SLV 01-07035

Details and patient eligibility

About

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

Full 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).

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

105 participants in 3 patient groups

Budesonide
Experimental group
Description:
Budesonide 9mg
Treatment:
Drug: Budesonide
bismuth
Experimental group
Description:
Bismuth mixture
Treatment:
Drug: Bismuth
Fiber
Sham Comparator group
Description:
Fiber preparation
Treatment:
Drug: Fiber

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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