N/A N=30 Diagnostic

Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)

Dyspepsia

Bottom Line

View on ClinicalTrials.gov: NCT01248221 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2013

Primary outcome: Primary: Gastric Emptying Half Time Measured by Scintigraphy — 65.9; 82.2 minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: [13C]-Spirulina platensis and 99mTc sulfur colloid (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Gastric Emptying Half Time Measured by Scintigraphy	65.9; 82.2	—
PRIMARY Gastric Emptying Half Time Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)	67.3; 82.5	—
SECONDARY Gastric Emptying at 60, 120, and 240 Minutes Measured by Scintigraphy	0.467; 0.318; 0.784; 0.545; 0.978; 0.844	—
SECONDARY Gastric Emptying at 60, 120, and 240 Minutes Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)	0.459; 0.324; 0.775; 0.556; 0.958; 0.847	—

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 of 2 scrambled eggs, a slice of wheat toast and 8 ounces of skim milk. The eggs will be double labeled with Technetium-99m (99mTc) sulfur colloid and 13C-Spirulina platensis. Scintigraphy is a diagnostic technique in which a two-dimensional picture of internal body tissue is produced through the detection of radiation emitted by a radioactive substance administered into the body. The location of a standard meal in the digestive system will be measured by images of the 99mTc sulfur colloid taken at periodic intervals before and after the standard meal. The 99mTc Sulfur Colloid is approved by the FDA for use in medical diagnostic procedures. Spirulina platensis is blue - green algae, which is very similar to the naturally occurring spirulina sold in health food stores as a dietary supplement. The spirulina platensis has been labeled with the 13C stable isotope. 13C stable isotope labeling is inherently safe as 1.1% of all carbon in our bodies and in the food we eat is 13C. The presence of the 13C will be measured by breath samples at periodic intervals before and after a standard meal. The FDA considers 13C-Spirulina platensis to be investigational for the purposes of this study.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01248221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.