Trial Outcomes & Findings for Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT) (NCT NCT01248221)
NCT ID: NCT01248221
Last Updated: 2013-03-18
Results Overview
Gastric emptying half time is the time for half of the ingested solids to leave the stomach. This value was measured by standard 99m Tc scintigraphy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
4 hours after ingestion of standard meal
Results posted on
2013-03-18
Participant Flow
Subjects were recruited from public advertisement and the motility clinic at the Mayo Clinic in Rochester, Minnesota.
Participant milestones
| Measure |
Healthy 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.
|
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.
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|---|---|---|
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Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)
Baseline characteristics by cohort
| Measure |
Dyspeptic Subjects
n=15 Participants
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.
|
Healthy Subjects
n=15 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
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|---|---|---|---|
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Age Continuous
|
41.08 years
STANDARD_DEVIATION 14.90 • n=5 Participants
|
42.01 years
STANDARD_DEVIATION 14.46 • n=7 Participants
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41.54 years
STANDARD_DEVIATION 14.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Body mass index (BMI)
|
26.75 kg/m^2
STANDARD_DEVIATION 8.0 • n=5 Participants
|
27.21 kg/m^2
STANDARD_DEVIATION 6.0 • n=7 Participants
|
26.98 kg/m^2
STANDARD_DEVIATION 6.95 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hours after ingestion of standard mealGastric emptying half time is the time for half of the ingested solids to leave the stomach. This value was measured by standard 99m Tc scintigraphy.
Outcome measures
| Measure |
Healthy Subjects
n=15 Participants
The subject will consume the test meal containing \[13C\]-Spirulina platensis and Technetium-99m (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.
|
Dyspeptic Subjects
n=15 Participants
The subject will consume the test meal containing \[13C\]-Spirulina platensis and Technetium-99m (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.
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|---|---|---|
|
Gastric Emptying Half Time Measured by Scintigraphy
|
65.9 minutes
Standard Deviation 14.7
|
82.2 minutes
Standard Deviation 34.6
|
PRIMARY outcome
Timeframe: 4 hours after ingestion of standard mealGastric emptying half time is the time for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.
Outcome measures
| Measure |
Healthy Subjects
n=15 Participants
The subject will consume the test meal containing \[13C\]-Spirulina platensis and Technetium-99m (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.
|
Dyspeptic Subjects
n=15 Participants
The subject will consume the test meal containing \[13C\]-Spirulina platensis and Technetium-99m (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.
|
|---|---|---|
|
Gastric Emptying Half Time Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)
|
67.3 minutes
Standard Deviation 14.0
|
82.5 minutes
Standard Deviation 33.2
|
SECONDARY outcome
Timeframe: 60, 120, and 240 minutes after ingestion of standard mealThe scintigraphic gastric emptying (GE) metric is the proportion of tracer emptied from the stomach at time, t.
Outcome measures
| Measure |
Healthy Subjects
n=15 Participants
The subject will consume the test meal containing \[13C\]-Spirulina platensis and Technetium-99m (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.
|
Dyspeptic Subjects
n=15 Participants
The subject will consume the test meal containing \[13C\]-Spirulina platensis and Technetium-99m (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.
|
|---|---|---|
|
Gastric Emptying at 60, 120, and 240 Minutes Measured by Scintigraphy
GE 60 minutes
|
0.467 proportion of tracer
Standard Deviation 0.096
|
0.318 proportion of tracer
Standard Deviation 0.137
|
|
Gastric Emptying at 60, 120, and 240 Minutes Measured by Scintigraphy
GE 120 minutes
|
0.784 proportion of tracer
Standard Deviation 0.100
|
0.545 proportion of tracer
Standard Deviation 0.164
|
|
Gastric Emptying at 60, 120, and 240 Minutes Measured by Scintigraphy
GE 240 minutes
|
0.978 proportion of tracer
Standard Deviation 0.083
|
0.844 proportion of tracer
Standard Deviation 0.167
|
SECONDARY outcome
Timeframe: 60, 120, and 240 minutes after ingestion of standard mealA multiple linear regression model approach was used to estimate gastric emptying based on the breath test samples at each time point. Gastric emptying (GE) metric is the proportion of tracer emptied from the stomach at time, t.
Outcome measures
| Measure |
Healthy Subjects
n=15 Participants
The subject will consume the test meal containing \[13C\]-Spirulina platensis and Technetium-99m (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.
|
Dyspeptic Subjects
n=15 Participants
The subject will consume the test meal containing \[13C\]-Spirulina platensis and Technetium-99m (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.
|
|---|---|---|
|
Gastric Emptying at 60, 120, and 240 Minutes Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)
GE 60 minutes
|
0.459 proportion of tracer
Standard Deviation 0.103
|
0.324 proportion of tracer
Standard Deviation 0.131
|
|
Gastric Emptying at 60, 120, and 240 Minutes Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)
GE 120 minutes
|
0.775 proportion of tracer
Standard Deviation 0.111
|
0.556 proportion of tracer
Standard Deviation 0.158
|
|
Gastric Emptying at 60, 120, and 240 Minutes Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)
GE 240 minutes
|
0.958 proportion of tracer
Standard Deviation 0.047
|
0.847 proportion of tracer
Standard Deviation 0.142
|
Adverse Events
Healthy Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dyspeptic Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place