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No x-rays needed: new light-based test may spot bowel slowdowns in kids

NCT ID NCT06911749

Diagnosis Sponsor: Dr. med. Sonja Diez Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a new way to measure how fast food moves through the gut in children with chronic constipation or other bowel emptying disorders. Instead of X-rays, it uses a special light-based imaging technique (MSOT) combined with a safe dye (ICG) and MRI scans. The goal is to find which part of the bowel is slow, so doctors can choose the best treatment. The study will include 20 children and a small group of healthy adults.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Indocyanine Green (ICG) contrast agent
What this could lead to
If successful, this could provide a safer, radiation-free way to diagnose bowel movement problems in children and help guide personalized treatment.
What could go wrong
This is a small, early-phase study with only 20 participants, so results may not apply to all children. The MSOT technique is not yet standard and may not work as expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patient Group * Written informed consent from the participant (starting at age 6). * Written informed consent from the legal guardian(s). * Suspected or confirmed diagnosis of chronic defecation disorder. * Age ≤ 18 years. * Willingness and ability to participate, with sufficient German language skills to understand the informed consent document. Control Group * Written informed consent from the participant. * Age \> 18 years. * BMI \< 25 or medical suitability for MSOT examination as assessed by a physician. * Willingness and ability to participate, with sufficient German language skills to understand the informed consent document. Exclusion Criteria: * Age \< 1 year. * Pregnancy or breastfeeding. * Tattoos in the examination area. * Subcutaneous fat tissue thickness \> 3 cm. * Known hypersensitivity to ICG, sodium iodide, or iodine. * Thyroid dysfunction, including hyperthyroidism or focal/diffuse thyroid autonomy. * Recent thyroid function testing with radioactive iodine treatment (within two weeks before or after the study). * Impaired renal function. * Use of specific medications, including: * Beta-blockers, * Anticonvulsants, * Cyclopropane, * Bisulfite compounds, * Haloperidol, * Heroin, * Meperidine, * Metamizole, * Methadone, * Morphine, * Nitrofurantoin, * Opium alkaloids, * Phenobarbital, * Phenylbutazone, * Probenecid, * Rifamycin, * Any injection containing sodium bisulfite. * General contraindications for MRI, such as electrical implants (e.g., pacemakers, perfusion pumps). * Severe claustrophobia preventing MRI examination.

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Conditions

The condition(s) this trial relates to.

constipation disorder Hirschsprung disease intestinal motility disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic constipation Hirschsprungs disease Intestinal transit disorder Slow transit constipation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospital Erlangen, Pediatric Surgery

    RECRUITING

    Erlangen, Bavaria, 91054, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.