Could a common cholesterol drug ease chronic diarrhoea?
NCT ID NCT07042165
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 4 times
Summary
This study tests whether atorvastatin, a drug typically used for cholesterol, can reduce bile acid production and improve symptoms in people with bile acid diarrhoea (BAD). Twenty adults with moderate-to-severe BAD will receive atorvastatin and a placebo in random order, each for four weeks. The goal is to see if the drug lowers bile acid levels and reduces stool frequency and urgency.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- atorvastatin
- What this could lead to
- If it works, this could offer a new treatment option for bile acid diarrhoea, reducing symptoms like stomach pain and urgent bowel movements.
- What could go wrong
- This is a small, early proof-of-concept trial with only 20 participants. The results may not apply to everyone, and atorvastatin may not improve symptoms or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2025
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bile acid diarrhea are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, 2900, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.