Gentofte Hospital
Hellerup, Denmark
Not recruiting
Study on the Effects of Atorvastatin in Patients with Moderate to Severe Bile Acid Diarrhea
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the treatment of bile acid diarrhea, a condition where the body produces too much bile acid, leading to frequent and watery bowel movements. The study will use a medication called Atorvastatin, which is commonly used to lower cholesterol levels, to see if it can also help reduce the production of bile acids in people with this condition. Participants in the study will receive either Atorvastatin or a placebo, which looks like the medication but does not contain any active ingredients.
The purpose of the study is to determine if Atorvastatin can effectively lower the levels of bile acids in the body, which may help improve symptoms of bile acid diarrhea. The study will involve taking the medication orally in the form of a film-coated tablet. Participants will be monitored over a period of time to assess changes in their symptoms and the levels of bile acids in their body.
Throughout the study, participants will be asked to keep a diary of their bowel movements to help researchers understand the effects of the treatment. The study aims to provide valuable information on whether Atorvastatin can be a beneficial treatment option for those suffering from moderate to severe bile acid diarrhea.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
4 criteria
- Must have a confirmed diagnosis of moderate to severe bile acid diarrhoea. This means a test called the SeHCAT test shows a result of 10% or less.
- Open to both males and females.
- Participants should be within the specified age range for the study.
- Participants should not be part of a vulnerable population, meaning they should be able to give informed consent and participate fully in the study.
Who cannot join the trial?
6 criteria
- Patients who are not diagnosed with bile acid diarrhoea cannot participate. Bile acid diarrhoea is a condition where the body produces too much bile acid, leading to frequent, watery bowel movements.
- Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
- Patients who are not willing to follow the study procedures cannot participate.
- Patients who are pregnant or breastfeeding cannot participate.
- Patients with other significant health issues that might interfere with the study cannot participate.
- Patients who are currently participating in another clinical trial cannot participate.
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Investigated drugs
Atorvastatin is a medication commonly used to lower cholesterol levels in the blood. In this clinical trial, it is being tested to see if it can also reduce the production of bile acids in the body. Bile acids are substances that help digest fats, but when they are produced in excess, they can cause diarrhea. The trial aims to find out if atorvastatin can help manage this condition by decreasing bile acid production, which could potentially improve symptoms for patients with moderate to severe bile acid diarrhea.
What is already known about the treatment
Atorvastatin – Atorvastatin is administered orally in the form of a tablet. It is currently being studied for its potential use in treating bile acid diarrhoea, a condition characterized by excessive bile acid in the intestines leading to diarrhea. The main therapeutic indication being investigated is its ability to reduce the production of bile acids in the body. At the molecular level, atorvastatin works by inhibiting an enzyme involved in cholesterol production, which in turn may lower bile acid synthesis. It is classified pharmacologically as a statin, a type of medication primarily used to lower cholesterol levels.
Investigated diseases
Bile Acid Diarrhea – Bile acid diarrhea is a condition characterized by chronic diarrhea due to the improper absorption of bile acids in the intestines. Bile acids are produced in the liver and help in the digestion of fats. When they are not absorbed properly, they can irritate the colon, leading to diarrhea. The condition often results in frequent, watery stools and can be associated with abdominal pain and bloating. It can occur as a primary condition or secondary to other diseases affecting the intestines. The progression involves persistent symptoms that can vary in intensity over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-521856-47-00Protocol code2025-521856-47-00Estimated enrolment20 patientsSponsorGentofte Hospital
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