Ongoing, recruitingTherapeutic use (Phase IV)Interventional

The effect of oral buspirone hydrochloride on esophageal motility, bolus transit and symptoms of dysphagia, in patients with poor esophageal motility: A randomized, double-blind, placebo controlled, cross-over trial with high resolution esophageal manometry and impedance.

This research wants to find out if a medicine called buspirone can improve swallowing problems (dysphagia) in people whose food pipe (oesophagus) doesn't squeeze food down properly. Often referred to as ineffective motility or absent peristalsis, these conditions make swallowing difficult. Participants will take either buspirone or a dummy pill (placebo) during different periods of the study. Doctors will use special tests, including one called high-resolution oesophageal manometry, to measure how well the food pipe is working and if symptoms get better. The study is particularly interested in how the oesophagus contracts when swallowing liquids.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

UZ Leuven

Enrolment target

Start

24 Oct 2024

ineffective motility or absent peristalsis

What is this study about?

This study is an important piece of research looking into problems with swallowing, a condition often called dysphagia. For many people, difficulty swallowing happens because the oesophagus – the tube that carries food from your mouth to your stomach – isn't squeezing properly. This can be due to 'ineffective motility' (meaning the squeezing is too weak) or 'absent peristalsis' (meaning there's no squeezing at all). These issues can make eating and drinking challenging and uncomfortable.

The main goal of this study is to see if a medication called buspirone can help the oesophagus move food down more effectively and reduce symptoms. Buspirone is already used for other medical conditions, and this study is exploring if it could also be a safe and effective treatment for specific swallowing difficulties. Participants will receive either the active drug or a placebo (a dummy pill that looks the same but contains no medicine), and their progress will be carefully monitored.

To understand how buspirone affects swallowing, researchers will use a specialised test called high-resolution oesophageal manometry. This test involves a thin, flexible tube that measures pressure changes in the oesophagus as you swallow. They will be particularly interested in how strongly the oesophagus contracts when you swallow a small amount of liquid. They will also track changes in your symptoms to see if you feel better on the medication.

Key takeaways

The study is testing a drug called buspirone for swallowing difficulties.
It's for people whose food pipe isn't squeezing food down properly.
Participants will take either buspirone or a dummy pill at different times.
Special tests will measure how the food pipe works and if symptoms improve.
The study is exploring if buspirone can help improve swallowing issues.
You can stop participating at any time.

Who may be eligible?

To join this study, generally, you need to be an adult aged 18 or older. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.

However, the most important requirement is that you have been diagnosed with specific problems with your oesophagus where it isn't squeezing food down properly. This is sometimes called 'ineffective motility' or 'absent peristalsis' by doctors. If you don't have these particular swallowing issues, this study might not be suitable for you.

There might be other health conditions or medications you are taking that would mean you couldn't join, but the research team would discuss all of these details with you during a screening appointment.

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?
Have you been told you have problems with your oesophagus not squeezing food down well (like ineffective motility or absent peristalsis)?
Are you able to attend clinic visits for tests, including oesophageal manometry?
Are you comfortable potentially taking a placebo (dummy pill) for some time during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be part of a 'cross-over' study. This means you will spend some time taking the active buspirone medication and other times taking a placebo (a dummy pill). Neither you nor your doctors will know which you are taking at any given time – this is called 'double-blind' and helps make the results fair. You will switch between the two treatments during the study.

Throughout the study, you will have several visits to the clinic. At these visits, you will undergo tests, including the high-resolution oesophageal manometry. This test involves swallowing a thin tube that measures movements in your food pipe. You will be asked to swallow different types of food or drink during the test. You will also be asked about your symptoms and how you are feeling after taking the study medication. The exact number of visits and the total duration aren't specified here, but the research team will explain it fully.

Potential risks and benefits

Taking part in a clinical trial offers the chance to contribute to medical knowledge and potentially help others with similar conditions in the future. While there's a chance buspirone could help improve your swallowing, there's no guarantee, and the placebo might not have any direct benefit. As with any medication, buspirone can have side effects, and the endoscopy procedure carries a small risk. However, the research team will monitor you closely for any problems. You can withdraw from the study at any time, for any reason, without it affecting your 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
Belgium

Common questions

What is dysphagia?

Dysphagia means having difficulty swallowing. It can feel like food or drink gets stuck, or it can be uncomfortable.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active drug. It helps researchers understand if the real medicine is truly working.

What is high-resolution oesophageal manometry?

It's a special test that measures the strength and coordination of your food pipe's muscles as you swallow. A thin tube is temporarily passed through your nose into your oesophagus.

Will I know if I'm taking the real drug or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know who is getting the active medicine and who is getting the placebo at any given time. This makes the results more reliable.

What does 'ineffective motility' mean?

It means the muscle squeezes in your food pipe (oesophagus) are too weak or not coordinated enough to push food and drink down effectively to your stomach.