Status:
COMPLETED
Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Conditions:
Dyspepsia
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this study is to compare stomach emptying using 13C-Spirulina platensis breath test and scintigraphy in healthy subjects and subjects with dyspepsia. Subjects will eat a standard meal ...
Detailed Description
The objective of this study is to compare gastric emptying assessed by the modified 13C spirulina breath test and scintigraphy in 30 subjects, i.e., 15 healthy subjects and 15 with dyspepsia. Gastric ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01248221
Start Date
December 1 2010
End Date
December 1 2011
Last Update
March 18 2013
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905