AuthorisedTherapeutic exploratory (Phase II)Interventional

Efficacy and safety of a novel dual pH-dependent delayed-release ColeseveLam for the trEatment of bile Acid diarrhoea: a Randomized, double-blind, parallel-group, placebo-controlled clinical trial - CLEAR

The CLEAR study is a research project looking into a new version of a medicine called Colesevelam. This new version is designed to work in a specific way in the gut. The study focuses on adults aged 18 and older who suffer from a condition called bile acid diarrhoea (BAD). Researchers want to find out if this new medicine is effective at reducing the symptoms of BAD, such as frequent bowel movements, and if it is safe to use. Half the participants will get the new medicine, and the other half will get a dummy medicine (placebo). This helps the researchers understand the true effects of the new treatment.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Monteresearch S.r.l.

Enrolment target

Start

02 Apr 2026

Bile acid diarrhoea

What is this study about?

This study, called CLEAR, is looking into a new way to treat a condition called bile acid diarrhoea (BAD). BAD happens when your body doesn't absorb bile acids properly, leading to symptoms like frequent, watery stools. Researchers have created a new version of an existing medicine, Colesevelam, which they hope will be more effective.

The main goal of the study is to see if this new medicine can help people achieve 'remission' from BAD. Remission here means a significant improvement in symptoms, based on specific medical criteria. Researchers will compare how well the new medicine works against a 'placebo', which is a dummy pill with no active medicine. This comparison is important to show whether any improvements are truly due to the new medicine or just random chance.

The study also looks at other important things, like how often people have bowel movements, and the consistency of their stools. They want to understand if the new treatment can help reduce the number of toilet visits and make stools more solid. By carefully tracking these changes, scientists can learn a lot about how good the new medicine is at improving the daily lives of people with BAD.

Key takeaways

Tests a new version of Colesevelam for bile acid diarrhoea.
Compares the new medicine to a dummy pill (placebo).
Focuses on reducing frequent or watery stools.
Open to adults aged 18 and over.
Requires daily symptom tracking via an e-diary.
Aims to find out if the new medicine is safe and effective.

Who may be eligible?

To join this study, participants must be 18 years old or older. The study is open to both men and women.

You would need to have been diagnosed with moderate to severe bile acid diarrhoea (BAD). This diagnosis would be confirmed by specific medical tests that measure bile acid levels in your body.

There might be other health conditions or medications that would prevent someone from joining, but these will be discussed in detail by the study doctor to ensure it's safe and appropriate for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of moderate to severe bile acid diarrhoea (BAD)?
Are you comfortable using an electronic diary to track your symptoms daily?
Are you able to attend regular study appointments?
Are you willing to potentially receive a placebo instead of the active medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be randomly assigned to either receive the new study medicine or a placebo (a dummy pill). You won't know which one you're getting, and neither will the study team. You'll take tablets by mouth. The main part of the study involves a period where you take a stable dose of the medicine for about a week (days 6-12). Throughout the study, you'll be asked to keep a daily electronic diary to record your symptoms, like how often you have bowel movements and their consistency. There will be screening visits to check if you're suitable, and then follow-up appointments and assessments to monitor your health and how the treatment is working. The total duration of your participation will be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial offers the chance to try a new treatment that might improve your condition if existing options haven't worked well for you. You'll also receive careful medical monitoring. However, as with any medicine, there's a possibility of side effects, though the study aims to assess the safety of this new treatment. We don't yet know if the new medicine will be effective. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is bile acid diarrhoea (BAD)?

BAD is a condition where your body doesn't absorb bile acids properly, leading to symptoms like frequent, watery stools.

What is Colesevelam?

Colesevelam is a medicine that helps to bind bile acids, which can reduce the symptoms of BAD.

What is a 'placebo'?

A placebo is a dummy pill that looks like the real medicine but contains no active ingredients. It helps researchers compare the effects of the actual medicine.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor the study team will know until after the study is complete.

How long will I be in the study?

The exact duration will be explained by the study team, but the main treatment period is about a week, followed by further monitoring.