Treatment of Bile Acid Diarrhoea With Atorvastatin

Launched by ASGER LUND, MD · Jun 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medicine called atorvastatin can help treat bile acid diarrhea, a condition that causes frequent, urgent watery bowel movements, stomach pain, and sometimes accidents. People with this condition often struggle with their daily lives, and current treatments don’t work well for everyone. The researchers want to see if atorvastatin can reduce the production of bile acids in the body and improve symptoms.

Adults aged 18 and older who have been diagnosed with moderate to severe bile acid diarrhea through a specific test (called SeHCAT) and who regularly have at least three bowel movements a day, including at least one watery stool, may be eligible to join. Participants will need to stop certain medications before and during the study and must be willing to follow the study’s rules closely. The trial will compare atorvastatin with a placebo (a dummy pill) in a way that neither the participants nor the researchers know who is taking which medicine until the study ends. This helps make the results more reliable. The study hasn’t started recruiting yet, but if you or a family member have this condition and meet the criteria, this trial might offer a new treatment option to explore.

Gender

ALL

Eligibility criteria

• 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 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
• • Active participation in any other clinical intervention trial (observational studies not included)
• • Other concomitant disease or treatment that according to the investigator's assessment makes the person unsuitable for study participation