Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)
Dyspepsia
About this trial
This is an interventional diagnostic trial for Dyspepsia focused on measuring Breath test, Dyspepsia, Gastric Emptying, Gastroparesis
Eligibility Criteria
Inclusion Criteria:
- Healthy male or non-pregnant, non-breastfeeding female volunteers
- 18-70 years of age
- Able to provide written informed consent before participating in the study
- Able to communicate adequately with the Investigator and to comply with the requirements of for the entire study, i.e., able to eat test meal and provide breath samples.
Additional inclusion criteria for dyspepsia patients:
- One or more of eight postprandial dyspeptic symptoms i.e., fullness, bloating, epigastric discomfort, early satiety, nausea, vomiting, belching, pain for a minimum of 3 months, OR
- Patients fulfilling the ROME-III criteria for functional dyspepsia,
- AND no symptom improvement under a standard dose proton-pump inhibitor (PPI) treatment,
- AND an upper gastrointestinal endoscopy negative for significant pathology that would explain symptoms done within the last 5 years prior to the study.
Exclusion Criteria:
- Severe nausea or vomiting precluding study assessments
- Use of medications that alter GI motility e.g., narcotics or medications with significant anticholinergic effects within two days of the study
- History of malabsorption due to mucosal disease, pancreatic disease, liver dysfunction, or other causes
- Abdominal surgery other than appendectomy, cholecystectomy, tubal ligation or hysterectomy
- Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that may interfere with the objectives of the study
- Patients who are allergic to eggs, wheat, or milk, or unwilling to consume these products
- Patients who have taken any investigational medications within the past 30 days.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Healthy subjects
Dyspeptic subjects
The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.