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Effect of the Sequestrant Colesevelam in Bile Acid Diarrhoea

NCT03876717 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2022-08-23

No results posted yet for this study

Summary

Bile acid diarrhoea is a chronic disease that impairs quality of life. One in 100 has the condition and many suffer from the disease without knowing. The current test is called SeHCAT and is expensive and time-consuming and is unavailable in many places, including the US. The disease is often misdiagnosed as irritable bowel syndrome and estimated one third of patients with irritable bowel syndrome of the mixed type and the diarrhoea predominant type suffer from bile acid diarrhoea without knowing.

A blood test called 7α-hydroxy-4-cholestene-3-one (C4) could make it much easier to diagnose bile acid diarrhoea.

To establish the new test, the results of both C4 and SeHCAT are compared with the treatment effect of the drug called colesevelam.

We invite patients who are referred for the SeHCAT test to participate in the trial. The SeHCAT test takes two days that are one week apart. The study patients register stool habits with a diary in the week between the SeHCAT visits. Based on the diary results, we screen for eligibility; e.g. a certain degree/severity of diarrhoea is required for participation. We treat eligible study patients (i.e those with diarrhoea) with either colesevelam or placebo (medicine without effect) that is randomly assigned. 170 study patients need to complete the treatment.

We aim to validate (ie. compare) both the C4-test and the SeHCAT test with the colesevelam treatment response as the reference.

Conditions

  • Bile Acid Malabsorption
  • Chronic Diarrhea

Interventions

DRUG

Colesevelam Hydrochloride

Colesevelam is a sequestrant that binds bile acids in the intestinal lumen, the bile acids are then excreted with the feces. Colesevelam is registered for treating hypercholesterolemia but it is as other sequestrants (e.g. cholestyramine and colestipol) effective against bile acid diarrhoea.

DRUG

Placebo oral capsule

Inactive placebo tablets over-encapsulated with DB caps AAA

Sponsors & Collaborators

  • Pierre and Marie Curie University

    collaborator OTHER

  • Lars Kristian Munck

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-25
Primary Completion
2021-07-01
Completion
2022-02-13

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876717 on ClinicalTrials.gov