Study on the Effects of Atorvastatin in Patients with Moderate to Severe Bile Acid Diarrhea

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What is this study about?

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.

1 beginning of the trial

Upon joining the study, the participant will be informed about the trial’s purpose, which is to investigate whether atorvastatin can reduce the production of bile acids in individuals with moderate to severe bile acid diarrhea.

The participant will be required to provide consent to participate in the study after understanding the trial’s objectives and procedures.

2 initial assessment

The participant will undergo an initial assessment to confirm eligibility, which includes a SeHCAT test result of 10% or less, indicating moderate to severe bile acid diarrhea.

This assessment ensures that the participant meets the criteria necessary to proceed with the trial.

3 placebo treatment period

The participant will begin the trial with a period of taking a placebo, which is a tablet that looks like the medication but does not contain the active substance.

The placebo is taken orally as a film-coated tablet, following the instructions provided by the study team.

4 atorvastatin treatment period

Following the placebo period, the participant will start taking atorvastatin, a medication used to lower cholesterol, which in this study is being tested for its effect on bile acid production.

The participant will take atorvastatin in a dosage of 40 mg orally as a film-coated tablet, as directed by the study team.

5 monitoring and data collection

Throughout the trial, the participant will be monitored for changes in bile acid production, specifically measuring the concentration of a marker called C4.

The participant will also be asked to keep a 7-day stool diary to record the frequency and consistency of stools, which will help assess the impact of the treatment.

6 end of trial

At the end of the trial, the participant’s data will be analyzed to compare the effects of atorvastatin versus the placebo on bile acid production and stool characteristics.

The participant will be informed about the study’s findings and any potential implications for their health.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Gentofte Hospital	Hellerup	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.08.2025

Trial locations

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.

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 ID:

2025-521856-47-00

Protocol code:

2025-521856-47-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Effects of Atorvastatin in Patients with Moderate to Severe Bile Acid Diarrhea

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?