Treatment of Microscopic Colitis

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)

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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