RecruitingNAINTERVENTIONAL

MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders

This study, run by doctors in Erlangen, Germany, is exploring new ways to understand and treat long-term bowel emptying issues in children aged 0-17. This includes common problems like chronic constipation, as well as conditions like Hirschsprung's disease. The research uses two special scanning techniques, MSOT and MRI, to see how food moves through the gut. Unlike X-rays, these methods don't use radiation. MSOT uses a special dye that's swallowed, while MRI looks at how the gut muscles are working. The goal is to get a clearer picture of what's causing a child's bowel problems. This detailed information could help doctors choose the best treatments, helping children feel better and improve their quality of life. Healthy adults are also invited to take part.

At a glance

Status

Recruiting

Phase

Sponsor

Dr. med. Sonja Diez

Enrolment target

Start

15 Apr 2025

Estimated completion

01 Jun 2026

Chronic Constipation Slow Transit Constipation Intestinal Transit Disorder Hirschsprungs Disease

What is this study about?

This research study is being carried out by doctors at the University Hospital Erlangen in Germany. They are looking for new and better ways to understand and treat long-term bowel emptying problems in children and teenagers (from birth up to 17 years old). These problems can range from common chronic constipation to other conditions like Hirschsprung's disease.

Currently, it can be tricky to figure out exactly why some children have these issues. This study aims to use two advanced, radiation-free scanning methods to get a clearer picture: Multispectral Optoacoustic Tomography (MSOT) and Magnetic Resonance Imaging (MRI). MSOT involves swallowing a special, harmless dye and then using light and sound waves to see how it moves through the gut. MRI uses strong magnets and radio waves to look at the gut in detail, including how the muscles are working. By using these new techniques, the researchers hope to precisely measure how fast or slow food moves through different parts of the bowel.

The main goal of this study is to help doctors tell the difference between different types of constipation, such as when the bowel muscles move too slowly, or when there's a blockage. This detailed information could help them choose the best and most targeted treatments. For example, if they know exactly which part of the bowel is slow, they might be able to stimulate that area more effectively. Ultimately, this research hopes to lead to better care and improved quality of life for children suffering from uncomfortable bowel problems.

Key takeaways

New study in Germany for children (0-17) with long-term bowel emptying problems.
Uses radiation-free scans (MSOT and MRI) to understand bowel movement.
Aims to improve diagnosis and treatment for conditions like chronic constipation.
Healthy adults (over 18) are also invited to join as controls.
Focuses on personalised insights for better therapy.
Participation involves special scans and swallowing a harmless dye.

Who may be eligible?

The study needs two groups of people: children and teenagers with bowel problems, and healthy adults as a comparison.

For the children's group (aged under 18), you might be able to join if you have a suspected or diagnosed long-term bowel emptying problem. You and your parents or guardians will need to give written permission and be able to understand the study information in German.

For the healthy adult group (aged over 18), you'll also need to give written permission and understand German. You should have a healthy weight (or be considered medically suitable by a doctor for the MSOT scan).

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.

Is the person with the bowel problem aged 0-17 years?
Do you (or your child's guardians) understand German and can give written permission?
If an adult control, are you over 18 and generally healthy?
No history of severe allergic reactions to iodine or certain medications?
No pacemakers or other electrical implants (for MRI scanner issues)?
No severe fear of small spaces that would prevent an MRI?

Answer every question to see your result.

What does participation involve?

If you or your child decide to take part, you'll visit the hospital at Erlangen, Germany. For children with bowel problems, the study involves using a new scanning technique called MSOT, which requires swallowing a special dye (called ICG). You or your child will also have an MRI scan, which doesn't use radiation or injected dyes for this study. The researchers will be collecting information about how food moves through the bowel using these methods to help them understand more about your condition. Healthy adult volunteers will also go through similar scanning procedures to provide a comparison. The total number of visits and the full duration of participation would be explained in more detail by the study team.

Potential risks and benefits

Taking part in this study could offer some benefits, as it uses advanced scanning techniques that might help doctors better understand your child's specific bowel problem, potentially leading to more targeted treatment. However, there's always a chance that the new methods might not directly improve your child's care during the study. Potential risks include possible side effects from the special dye (ICG) used in the MSOT scan, but these are generally rare. Some people might find the MRI scan uncomfortable, especially if they are worried about small spaces. You or your child can stop taking part in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University Hospital Erlangen, Pediatric Surgery
Verified postcode
Erlangen, Germany· Recruiting

Common questions

What kind of bowel problems is this study looking at?

This study is looking at long-term bowel emptying problems in children, including chronic constipation and conditions like Hirschsprung's disease.

Are the scans used in this study safe?

Yes, the MSOT and MRI scans used in this study do not use X-ray radiation. MSOT uses a safe dye you swallow, and MRI uses magnets and radio waves.

Will taking part help my child's constipation straight away?

This is a research study to gain more understanding. While the information found might help guide future treatments, it's not guaranteed to directly improve your child's condition during the study period itself.

What is the special dye (ICG) for?

The ICG dye is swallowed and helps the MSOT scanner see how things are moving through your child's bowel more clearly.

Who is running this study?

This study is being run by doctors from the Pediatric Surgery and Pediatrics departments at the University Hospital Erlangen in Germany.

How to find out more

Frederike Bieling

frederike.bieling@uk-erlangen.de +49 9131 85 32923 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.