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
Asger Lund, MD
20 participants
Oct 15, 2025
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
Plain Language Summary
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Interventions
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).
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)
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NCT07042165