Status:
RECRUITING
MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders
Lead Sponsor:
Dr. med. Sonja Diez
Conditions:
Chronic Constipation
Slow Transit Constipation
Eligibility:
All Genders
1+ years
Phase:
NA
Brief Summary
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 th...
Detailed Description
The term chronic defecation disorders encompasses a wide range of conditions in the current medical literature. Among them, idiopathic chronic constipation represents the central subgroup of patients,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06911749
Start Date
April 15 2025
End Date
June 1 2026
Last Update
September 3 2025
Active Locations (1)
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1
University Hospital Erlangen, Pediatric Surgery
Erlangen, Bavaria, Germany, 91054