RecruitingPhase 4NCT07042165

Treatment of Bile Acid Diarrhoea With Atorvastatin

Treatment of Bile Acid Diarrhoea With Atorvastatin (BASTA): A Randomised, Double-Blind, Placebo-Controlled, Crossover, Investigator-Initiated Trial


Sponsor

Asger Lund, MD

Enrollment

20 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Atorvastatin and a drug called Placebo for people with bile acid diarrhea and bile acid malabsorption. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtorvastatin

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).

DRUGPlacebo

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.


Locations(1)

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, Denmark

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NCT07042165


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