Treatment of Bile Acid Diarrhoea With Atorvastatin

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Bile Acid Diarrhea, Bile Acid Malabsorption

In brief

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.

Key facts

Study ID

NCT07042165

Run by

Asger Lund, MD

People needed

20

Starts

2025-10-15

Expected to finish

2026-12-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 aminotransferase ≥ 3 times upper limit of normal
• Crohn's disease, ulcerative colitis, celiac disease or lactose intolerance
• Previous intestinal resection or major intra-abdominal surgery incl. stoma (cholecystectomy and appendectomy not included)
• Nephropathy with estimated glomerular filtration rate < 45 ml/min/1,73 m2
• Plasma level of creatine kinase ≥ 5 times the upper limit of normal
• A recent stroke or transient ischemic attack (within 6 months)
• Any treatment or condition requiring acute or subacute medical or surgical intervention
• Hypothyroidism or hyperthyroidism, if not well regulated, at the discretion of the investigator
• Active or recent (within 6 months) clinically significant malignant disease (non-melanoma skin cancer not included), at the discretion of the investigator
• Alcohol consumption exceeding 12 units/week for women or 18 units/week for men, respectively. These thresholds are based on the limits of the European Association for the Study of the Liver
• Drug abuse, at the discretion of the investigator
• Fertile women not using any of the following contraceptive methods for the duration of the trial until at least 5 days after end of trial: Hormonal (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormone intrauterine devices (IUD), hormonal vaginal ring or transdermal hormonal patch) associated with inhibition of ovulation, chemical (copper IUD), sterilisation, vasectomised partner with a confirmatory test, or sexual abstinence per the investigator's discretion
• Pregnant or nursing women
• Known or suspected hypersensitivity to atorvastatin or any of the additives in the tablet
• Receipt of any investigational drug within 30 days prior to visit 0
• Concomitant treatment with any of the following (topical administration not included): ciclosporin, telithromycin, clarithromycin, delavirdin, stiripentol, ketoconazol, voriconazol, itraconazol, posaconazol, letermovir, ritonavir, lopinavir, atazanavir, indinavir, darunavir, bocepravir, telaprevir, elbasvir/grazoprevir, ledipasvir/sofosbuvir, erythromycin, niacin, ezetimibe, fusidic acid, gemfibrozil, colchicine, digoxin, warfarin
• Unable to speak or understand Danish or mental incapacity that preclude adequate understanding or cooperation or unwillingness to comply with trial requirements

Where it is running

• Center for Clinical Metabolic Research, Gentofte Hospital — Hellerup, Denmark (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.