Study on the Effectiveness and Safety of Colesevelam Hydrochloride for Patients with Idiopathic Bile Acid Diarrhea (BAD)

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What is this study about?

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.

1 beginning of the trial

Upon joining the study, you will be randomly assigned to one of three groups. Two groups will receive different doses of the active medication, colesevelam hydrochloride-MMX, and the third group will receive a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of this random assignment is to compare the effects of the medication with the placebo. Neither you nor the study team will know which group you are in, ensuring unbiased results.

2 medication administration

You will take the assigned tablets orally. The dosage and frequency will depend on the group you are assigned to. The study will provide specific instructions on how to take the tablets.

The duration of the medication administration is planned for 8 weeks. It is important to follow the instructions carefully and take the medication as directed.

3 monitoring and diary entries

Throughout the study, you will be asked to keep a daily diary. This diary will record your bowel movements, including the frequency and consistency of stools, using the 7-point Bristol Stool Form Scale (BSFS).

Regular entries in the diary are crucial for assessing the effectiveness of the treatment. You will need to complete a minimum of 3 consecutive days of diary entries or 4 nonconsecutive days within a 7-day period.

4 follow-up assessments

You will have follow-up assessments at weeks 2, 4, and 8. These assessments will evaluate your response to the treatment, focusing on changes in stool consistency and frequency.

The study aims to determine if there is a reduction in the number of days with loose stools and if there is an improvement in overall bowel movement patterns.

5 end of the trial

At the end of the 8-week period, a final assessment will be conducted to evaluate the overall effectiveness and safety of the treatment.

The study will compare the results between the different groups to determine the impact of the medication on idiopathic bile acid diarrhoea.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Spitalul Clinic Judetean De Urgenta Cluj	Cluj Napoca	Romania
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Sint-Lucas General Hospital	Brugge	Belgium
Aalborg University Hospital	Aalborg	Denmark
Spitalul Clinic Judetean Mures	Targu Mures	Romania
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
Vrije Universiteit Brussel	Jette	Belgium
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Steno Diabetes Center Zealand	Koege	Denmark
Ospedale Valduce	Como	Italy
Ckfnzldsy Ukpctlsomwolpi Sfyofrzzc	Woluwe-Saint-Lambert	Belgium
Svhmafib Cqjwim &jikdvorvk Ii Cvexwfjugxhfhcpbvb	Bucharest	Romania
Agbylw Uduvjbghos Hfkpjixg	Aarhus	Denmark
Aefrdyp Uljdi Szcgofpqj Lgdiij Dn Bijwpka	Bologna	Italy
Ultciknjck Or Attpxow	Edegem	Belgium
Hwskioki Vayq dhvmhnkx	Barcelona	Spain
Mguymbehay Sfadqc	Bucharest	Romania

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	30.06.2025
Denmark	Recruiting	30.06.2025
Italy	Recruiting	30.06.2025
Romania	Recruiting	30.06.2025
Spain	Recruiting	30.06.2025

Trial locations

Investigated drugs:

COLESEVELAM HYDROCHLORIDE

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.

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 ID:

2024-511993-55-00

Protocol code:

CB-01-33/01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of Colesevelam Hydrochloride for Patients with Idiopathic Bile Acid Diarrhea (BAD)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?