The prevalence of bile acid diarrhéa and the effect of treatment in patients with microscopic colitis

Phase 1

• Conditions: Microscopic colitisBile acid diarrhea; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2019-002762-12-DK
• Lead Sponsor: Zealand University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-25
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Suspected activity in MC, defined by Hjortswang criteria: 3 stools daily OR one watery (Bristol type 6or7) stools daily, as a mean over the last 6-7 days.
Proven microscopic colitis (collagenous, lymphocytic or incomplete) in biopsies from the last 6 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 29

Exclusion Criteria

Age < 18 years
Stoma
Pregnancy
Intestinal resection other than appendectomy
cholecystectomy
Other chronic intestinal disease with diarrhoea
Use of other constipation agent than loperamide
Systemic treatment with steroid within 2 weeks of the start of treatment
Suspected or proven gastrointestinal infection
Allergy to budesonide
Lack of compliance or understanding of the trial
If taking statin or fibrate therapy: unwilling to pause medical treatment against hypercholesterolaemia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the prevalence of bile acid diarrhea (BAD) in patients with active microscopic colitis (MC). The apperance of BAD is defined by watery stools and a raised level of 7alpha-hydroxy-4-cholesten-3-on (C4).;Secondary Objective: To investigate the effect of budesonide on the bile acid homeostasis assessed by changes in C4 and FGF19;Primary end point(s): Prevalence of BAD defined by fasting C4 levels > 46 ng/mL in patients with active MC;Timepoint(s) of evaluation of this end point: Analysis of the biobank blood samples after LSLV. Expected aprox. medio 2022