Azienda Ospedaliero-Universitaria Sant Andre
Rome, Italy
Recruiting
Study on the Effectiveness and Safety of Colesevelam Hydrochloride for Patients with Idiopathic Bile Acid Diarrhea (BAD)
Verified siteInvestigational
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying a condition known as idiopathic bile acid diarrhea (BAD). This is a type of diarrhea that occurs when the body has trouble absorbing bile acids, which are substances produced by the liver to help digest fats. The study is testing a new treatment called Colesevelam hydrochloride-MMX®, which is a modified-release tablet designed to help manage this condition. Participants in the study will be randomly assigned to receive either the active medication in two different dose regimens or a placebo, which looks like the medication but does not contain the active ingredient.
The purpose of the study is to evaluate how effective and safe the new tablet formulation is for patients with idiopathic bile acid diarrhea. The study will last for a period of eight weeks. During this time, participants will take the medication or placebo and will be monitored to see if there is an improvement in their symptoms, particularly in terms of stool consistency and frequency. The goal is to see if the treatment can reduce the number of days with loose stools and improve overall bowel movement patterns.
Participants will be assessed at different points during the study to determine if they are responding to the treatment. The main focus will be on whether there is a significant reduction in the number of days with loose stools, as well as any changes in the frequency of bowel movements. The study will also look at any side effects that may occur during the treatment period. This research aims to provide valuable information on the potential benefits of Colesevelam hydrochloride-MMX® for managing idiopathic bile acid diarrhea.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- Sign a written consent form to show you understand and agree to participate in the study.
- Be a man or woman who is at least 18 years old.
- Have a diagnosis or symptoms of bile acid diarrhoea (BAD), which is a type of digestive issue. This includes having a specific blood test result and experiencing certain bowel movement patterns.
- If you are a woman who can have children, you must use a reliable method of birth control, such as birth control pills, an intrauterine device (IUD), or have a partner who is sterile. Alternatively, you must practice true abstinence, meaning no sexual intercourse, if this is your usual lifestyle. Women who cannot have children or are postmenopausal must have been in that state for at least one year. A pregnancy test must be negative at the start of the study.
- Understand the purpose and details of the study, including any risks and side effects, and be able to follow the study requirements.
- Complete a diary of your symptoms for at least 3 consecutive days or 4 nonconsecutive days within a week before starting the study.
Who cannot join the trial?
9 criteria
- Patients who do not have a diagnosis of idiopathic bile acid diarrhoea (BAD) cannot participate. This is a condition where the body has trouble absorbing bile acids, leading to diarrhea.
- Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
- Patients who are not willing or able to follow the study procedures cannot participate.
- Patients who have other medical conditions that might interfere with the study cannot participate.
- Patients who are pregnant or breastfeeding cannot participate.
- Patients who are currently participating in another clinical trial cannot participate.
- Patients who have a history of substance abuse or alcohol abuse cannot participate.
- Patients who have had a recent major surgery cannot participate.
- Patients who have a known allergy to the study medication or its ingredients cannot participate.
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Responsive Responsive Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, BelgiumResponsive Katholieke Universiteit te Leuven
Leuven, Belgium
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
RecruitingNot finding your country?
Not sure what to do next?
Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
Investigated drugs
Colesevelam Hydrochloride is a medication used in this clinical trial to help manage a condition known as idiopathic bile acid diarrhoea (BAD). This condition can cause frequent and watery bowel movements. Colesevelam Hydrochloride works by binding to bile acids in the intestines, which can help reduce the symptoms of diarrhoea. In this study, a new modified-release tablet formulation of this medication is being tested to see how effective and safe it is for patients with BAD. The goal is to find out if this new formulation can improve stool consistency for those participating in the trial.
What is already known about the treatment
Colesevelam Hydrochloride – This medication is administered in the form of a modified-release tablet, taken orally. It is currently being studied in a phase II clinical trial to assess its effectiveness and safety for treating idiopathic bile acid diarrhoea (BAD). The main therapeutic use of colesevelam hydrochloride is to help manage symptoms of BAD, a condition characterized by chronic diarrhea due to bile acid malabsorption. At the molecular level, colesevelam works by binding to bile acids in the intestine, preventing their reabsorption and thereby reducing diarrhea. It is classified pharmacologically as a bile acid sequestrant.
Investigated diseases
Idiopathic Bile Acid Diarrhea – Idiopathic bile acid diarrhea is a condition characterized by chronic diarrhea due to excessive bile acids in the colon. It occurs when the body produces or releases more bile acids than the small intestine can absorb. This leads to an increase in water secretion in the colon, resulting in loose, watery stools. The condition is termed "idiopathic" because the exact cause is unknown, although it is thought to involve a dysfunction in bile acid regulation. Symptoms often include frequent bowel movements, urgency, and abdominal discomfort. The condition can significantly impact daily life due to the unpredictability and frequency of symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511993-55-00Protocol codeCB-01-33/01Estimated enrolment150 patientsSponsorCosmo Technologies Limited
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?