Treatment of Bile Acid Diarrhoea With Atorvastatin (NCT07042165) | Clinical Trial Compass
RecruitingPhase 4
Treatment of Bile Acid Diarrhoea With Atorvastatin
Denmark20 participantsStarted 2025-10-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age 18 years or above
* Self-identification as White
* Confirmed moderate-severe bile acid diarrhoea with a SeHCAT test result of ≤ 10 %
* Reported number of average daily stools ≥ 3 stools per day
* Reported number of average daily watery (6 or 7 on the Bristol Stool Chart) stools ≥ 1 stools per day(30)
* Informed and written consent
Exclusion Criteria:
* Unwillingness to pause any of the following medications during the trial: bile acid sequestrants, morphine medication, liraglutide or anti-constipation medication (e.g., lactulose, laxoberal, magnesia)
* Unwillingness to pause any anti-diarrhoea medication (e.g., imodium) from 3 days before initiation of each stool diary until after the respective visit
* If regularly administering psyllium or metformin, unwillingness to agree to a stable dose of psyllium or metformin throughout the trial
* Concomitant use of any drug in the GLP-1 receptor agonist drug class with the exception of paused liraglutide, see above
* Concomitant use of any kind of insulin medication
* Planned major changes in food consumption throughout the trial, including planned weight loss attempts
* Prior use of any statin within the recent 6 months
* Intake of larger quantities of grapefruit juice during trial participation, at the discretion of the investigator
* History of/present hepatobiliary disorder (except for simple metabolic dysfunction-associated fatty liver disease) and/or alanine aminotransferase and/or serum aspartate a…
What they're measuring
1
Reduction in bile acid synthesis measured via 7alpha-Hydroxy-4-cholesten-3-on (C4)
Timeframe: The end of week 4 and the end of week 12.