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Treatment of Bile Acid Diarrhoea With Atorvastatin

NCT07042165 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-02

No results posted yet for this study

Summary

Bile acid diarrhoea (BAD) is a socially debilitating disease with stomach pain, high stool frequency, urgency, and faecal incontinence as the main symptoms. Studies estimate that 1-2% of the population suffers from the disease.

There is an unmet need for more treatment options in patients suffering from BAD.

The investigators hypothesise that atorvastatin treatment lowers bile acid synthesis in patients with bile acid diarrhoea. The investigators will investigate this hypothesis in the current study, BASTA, which is a Randomised, Double-Blind, Placebo-Controlled, Crossover, Proof of Concept, Investigator-Initiated, Trial.

Conditions

  • Bile Acid Diarrhea
  • Bile Acid Malabsorption

Interventions

DRUG

Atorvastatin

Participants will be orally administering one tablet daily of 40 mg Atorvastatin for two weeks followed by two tablets daily for two weeks (totalling 80 mg daily).

DRUG

Placebo

Placebo tablets are manufactored by the Central Pharmacy of the Capital Region of Denmark and are identical to the IMP except with the active ingredient (atorvastatin) omitted. Participants will be orally administering one tablet daily for two weeks followed by two tablets daily for two weeks.

Sponsors & Collaborators

  • Fonden til Lægevidenskabens Fremme

    collaborator OTHER

  • Prosektor Axel Søeborg Ohlsens Mindelegat

    collaborator OTHER

  • Læge Sofus Carl Emil Friis og Hustru Olga Doris Friis' Legat

    collaborator OTHER

  • Aase and Ejnar Danielsens Foundation

    collaborator OTHER

  • Asger Lund, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

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 NCT07042165 on ClinicalTrials.gov