Gastrointestinal Motility
Conditions
Brief summary
This clinical trial aims to characterize a novel method of imaging the gastrointestinal tract in healthy subjects. The method is using laser-light and soundwaves and it is performed in a similar manner as conventional ultrasound. It is radiation-free and non-invasive. Participants will ingest food mixed with the clinically-registered dye Indocyanine green. Researchers will measure the signal of the dye over different segments of the gastrointestinal tract, visualizing gastrointestinal transit.
Detailed description
This clinical trial aims to assess gastrointestinal transit by using contrast-enhanced multispectral optoacoustic tomography (MSOT). MSOT is able to visualize not only endogenous chromophores like hemoglobin but also exogenous chromophores such as Indocyanine green (ICG). Healthy subjects will ingest three different standardized meals, all of which are mixed with ICG. By measuring the signal intensity of ICG during gastrointestinal transit, gut motility can be assessed non-invasive and radiation free. The goal is to compare transit times for different standardized meals, which are liquid, mushy, and solid.
Interventions
DIAGNOSTIC_TESTContrast-enhanced multispectral optoacoustic tomography
Ingestion of ICG-labeled food and 10 measurements with MSOT, 1 before ingestion of food, 8 afterwards, each after 60 minutes, 1 measurement 24 hours after ingestion
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Subjects will ingest three different standardized meals called breakfast 1, breakfast 2, and breakfast 3. They will ingest one meal per day, there is a minimum of 48 hours between measurement days. Every subject will ingest every meal.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age over 18 years * Written informed consent
Exclusion criteria
General: * Pregnancy * Breastfeeding mothers * Tattoo in the area of the examination * Subcutaneous fat tissue over 3 cm * Chronic or acute diseases of the gastrointestinal tract or symptoms suggesting such a disease * Acute diseases requiring treatment * Lack of written consent ICG related: * Known hypersensitivity to ICG, sodium iodide or iodine. * Hyperthyroidism, focal or diffuse thyroid autonomy. * Timely close treatment to check thyroid function with ingestion of radioactive iodine (within two weeks before or after the study) * Impaired renal function * Taking the following medications: Beta blockers, anticonvulsants, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin, any injection containing sodium bisulfite
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transit-times of different segments of the gastrointestinal tract | 2 days | Transit-times of the gastrointestinal passage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Signal-intensity of ICG | 2 days | Measured with MSOT in arbitrary units |
Countries
Germany
Contacts
Primary ContactEmmanuel Nedoschill, MD
Outcome results
None listed