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New treatment option for Chronic Constipation
Official title MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders
ClinicalTrials.gov ID: NCT06911749
What this study is testing
- What it's testing
- The project presented here is a monocentric clinical study conducted by the Pediatric Surgery and Pediatrics departments of the University Hospital Erlangen. The study aims to experimentally expand the diagnostic approach for patients aged 0-17 years suffering from chronic bowel emptying disorders, regardless of any underlying causal or previously treated conditions.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Erlangen, Bavaria, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Erlangen, Bavaria, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.