AuthorisedPhase III and phase IV (Integrated)Interventional

Clinical trial on the assessment of mucosal visualization quality and diagnostic performance in small bowel capsule endoscopy using different preparation protocols

This research study is about finding the best way to prepare your body for a special test called a capsule endoscopy, often called a 'camera pill' test. This test involves swallowing a tiny camera that takes pictures as it travels through your digestive system, especially your small bowel. The study will compare two different preparation methods to see which one helps doctors get the clearest pictures and find any health problems more easily. It will also look at how patients feel about the preparations and how quickly the camera moves through the gut. This helps improve how we use this test to diagnose conditions.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Hospital Universitario La Paz

Enrolment target

156

Start

21 Jan 2025

Comparison of diagnostic tools

What is this study about?

Imagine swallowing a tiny camera that travels through your digestive system, taking thousands of pictures along the way. This is called a capsule endoscopy, and it's a really helpful way for doctors to look inside your small bowel, an area that's hard to reach with other methods. Before you swallow the camera pill, you usually need to prepare your gut, often by taking special drinks or medications to make sure the inside of your bowel is clean enough for clear pictures.

This particular study wants to find out the very best way to prepare for this camera pill test. They are comparing two different preparation methods. One method uses a common bowel cleansing drink called MOVIPREP, and the other uses a different liquid called Aero-red. The main goal is to see which preparation allows doctors to get the clearest view of your small bowel. If the pictures are clearer, it's easier for doctors to spot any potential problems like inflammation, bleeding, or other changes.

Beyond just seeing clearly, the study will also look at whether one preparation helps doctors find more health problems (this is called 'diagnostic yield'). They'll also check how quickly the capsule moves through your stomach and small bowel, and how you, as a patient, feel about taking the preparation. Finding an effective yet comfortable preparation is important for both accurate diagnosis and patient experience. This research helps improve the capsule endoscopy test for everyone who needs it.

Key takeaways

This study compares two ways to prepare for a 'camera pill' test.
It aims for clearer images to help doctors find health problems.
The study also checks how patients tolerate the preparations.
Both men and women over 18 can potentially join.
Participation involves taking preparation and swallowing a camera pill.

Who may be eligible?

To take part in this study, you need to be at least 18 years old. There's no upper age limit, so people of all adult ages can join.

Both men and women are welcome to participate in this research. The study needs a variety of people to get a good understanding of how the preparations work.

Quick self-check

Are you 18 years old or older?
Are you male or female?
Are you considering a camera pill test for your small bowel?
Are you able to follow instructions for taking bowel preparation?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you would be asked to follow one of the two preparation methods before your capsule endoscopy. This involves taking specific drinks or liquids as instructed. You will then swallow the small camera pill, which will naturally pass through your digestive system. During this time, you won't need to stay in the hospital, but you'll wear a small recording device.

After the test, you'll be asked to complete a short questionnaire about your experience with the preparation, focusing on how well you tolerated it. Doctors will then analyse the images from your camera pill to assess the cleanliness of your bowel and look for any findings. The total duration of your active involvement typically revolves around the day of your preparation and the day of your camera pill test.

Potential risks and benefits

Taking part in this study might help us find better ways to prepare for capsule endoscopy tests in the future, which could benefit many patients. You might also find out more about your own digestive health. There are some potential risks, similar to those that can happen with any capsule endoscopy, like the camera getting stuck, although this is rare. The preparation medicines can also cause side effects like nausea or bloating. Remember, you can decide to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Spain

Common questions

What is a 'camera pill' test?

It's a small capsule you swallow that contains a tiny camera. It takes pictures of your small bowel as it travels through your body.

Why do I need to prepare for this test?

Preparing your bowel helps clear out anything that might block the camera's view, allowing doctors to see clearer pictures and make a better diagnosis.

What are MOVIPREP and Aero-red?

These are the two different types of liquid preparations being compared in this study. They help clean out your bowel before the camera pill test.

Will I know which preparation I'm getting?

The study design usually means you won't know which preparation you receive until it's given to you; this helps ensure fair comparison.

How long does the camera pill stay inside me?

The camera usually passes through your system within 24 to 48 hours and is passed naturally with a bowel movement.