DyspepsiaNCT01248221
Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)
A study testing [13C]-Spirulina platensis and 99mTc sulfur colloid in people with Dyspepsia, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspepsia
- What is being tested?
- [13C]-Spirulina platensis and 99mTc sulfur colloid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: [13C]-Spirulina Platensis GEBT - Dual-Label Validation Study
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.
Read more
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.
Read the 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 emptying will be simultaneously assessed by both methods using a dual-labeled meal. It is anticipated that the gastric emptying half-time (t½) values based on the 13C breath excretion values will compare with the gold standard, scintigraphy, in which the "true" t½ values are obtained. The aims of this study are to estimate factors necessary for converting exhaled 13C concentrations to gastric emptying half-time, as measured by scintigraphy, in healthy subjects and patients with dyspepsia.
For each potential participant, a screening visit will be conducted within 4 weeks prior to the study visit. During the screening visit, informed consent will be obtained, and a physical exam will be conducted by a trained investigator. Participants will then be free to leave the test site. A urine pregnancy test for women of child-bearing potential will be completed within 48 hours prior to exposure to radiation. After an overnight (minimum 8 hour) fast, the participants will return to the study center, at which time the dual-label Gastric Emptying Test will be administered. A baseline breath sample will be collected in duplicate by having the subject blow through a straw into a collection tube. The test meal will be prepared by personnel at the test site after the subject arrives. Step-by-step test meal preparation instructions are provided with the GEBT kit. The patient will consume the test meal containing [13C]-Spirulina and 99mTc sulfur colloid in no more than 10 minutes. 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.
As the cooked egg is triturated by the stomach, it passes through the pylorus into the intestine where the [13C]-Spirulina platensis is digested, absorbed, and metabolized giving rise to labeled carbon dioxide expired in the breath. Breath samples, collected before and after the test meal, are shipped overnight to Advanced Breath Diagnostics for analysis by Gas Isotope Ratio Mass Spectroscopy. By measuring the change in excretion over time, the rate of gastric emptying can be determined.
- Conditions
- Dyspepsia
- Being tested
- [13C]-Spirulina platensis and 99mTc sulfur colloid
- Keywords
- Breath test, Dyspepsia, Gastric Emptying, Gastroparesis
- Medical subject headings
- Dyspepsia, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[13C]-Spirulina platensis and 99mTc sulfur colloidDrug
The subject will consume the test meal containing 13C-Spirulina and 99mTc sulfur colloid in no more than 10 minutes. 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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | 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. Receives: Drug: [13C]-Spirulina platensis and 99mTc sulfur colloid |
| Dyspeptic subjects | Experimental | 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. Receives: Drug: [13C]-Spirulina platensis and 99mTc sulfur colloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Emptying Half Time Measured by Scintigraphy
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.
Measured: 4 hours after ingestion of standard meal
Gastric Emptying Half Time Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)
Gastric 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.
Measured: 4 hours after ingestion of standard meal
Secondary outcomes (2)
Gastric Emptying at 60, 120, and 240 Minutes Measured by Scintigraphy
The scintigraphic gastric emptying (GE) metric is the proportion of tracer emptied from the stomach at time, t.
Measured: 60, 120, and 240 minutes after ingestion of standard meal
Gastric Emptying at 60, 120, and 240 Minutes Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)
A 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.
Measured: 60, 120, and 240 minutes after ingestion of standard meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR), Advanced Breath Diagnostics, LLC
- Investigators
- Adil E Bharucha, MBBS, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248221
- Sponsor's protocol ID
- 09-006643
- Other IDs
- P01DK068055, UL1RR024150
- Status last verified
- Feb 2013
- First submitted
- 23 Nov 2010
- Last updated
- 18 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [13C]-Spirulina Platensis GEBT - Dual-Label Validation Study
- ClinicalTrials.gov ID
- NCT01248221
- Acronym / sponsor ID
- 09-006643
- Conditions
- Dyspepsia
- Keywords
- Breath test, Dyspepsia, Gastric Emptying, Gastroparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR), Advanced Breath Diagnostics, LLC
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Posted 18 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 emptying will be simultaneously assessed by both methods using a dual-labeled meal. It is anticipated that the gastric emptying half-time (t½) values based on the 13C breath excretion values will compare with the gold standard, scintigraphy, in which the "true" t½ values are obtained. The aims of this study are to estimate factors necessary for converting exhaled 13C concentrations to gastric emptying half-time, as measured by scintigraphy, in healthy subjects and patients with dyspepsia.
For each potential participant, a screening visit will be conducted within 4 weeks prior to the study visit. During the screening visit, informed consent will be obtained, and a physical exam will be conducted by a trained investigator. Participants will then be free to leave the test site. A urine pregnancy test for women of child-bearing potential will be completed within 48 hours prior to exposure to radiation. After an overnight (minimum 8 hour) fast, the participants will return to the study center, at which time the dual-label Gastric Emptying Test will be administered. A baseline breath sample will be collected in duplicate by having the subject blow through a straw into a collection tube. The test meal will be prepared by personnel at the test site after the subject arrives. Step-by-step test meal preparation instructions are provided with the GEBT kit. The patient will consume the test meal containing [13C]-Spirulina and 99mTc sulfur colloid in no more than 10 minutes. 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.
As the cooked egg is triturated by the stomach, it passes through the pylorus into the intestine where the [13C]-Spirulina platensis is digested, absorbed, and metabolized giving rise to labeled carbon dioxide expired in the breath. Breath samples, collected before and after the test meal, are shipped overnight to Advanced Breath Diagnostics for analysis by Gas Isotope Ratio Mass Spectroscopy. By measuring the change in excretion over time, the rate of gastric emptying can be determined.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Drug: [13C]-Spirulina platensis and 99mTc sulfur colloidThe 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 | Experimental | Drug: [13C]-Spirulina platensis and 99mTc sulfur colloidThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [13C]-Spirulina platensis and 99mTc sulfur colloidThe subject will consume the test meal containing 13C-Spirulina and 99mTc sulfur colloid in no more than 10 minutes. 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. | Drug | Dyspeptic subjects, Healthy subjects |
Primary outcome
Gastric Emptying Half Time Measured by Scintigraphy
Time frame: 4 hours after ingestion of standard meal
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.
Gastric Emptying Half Time Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)
Time frame: 4 hours after ingestion of standard meal
Gastric 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.
2 secondary outcomes
Gastric Emptying at 60, 120, and 240 Minutes Measured by Scintigraphy
Time frame: 60, 120, and 240 minutes after ingestion of standard meal
Gastric Emptying at 60, 120, and 240 Minutes Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)
Time frame: 60, 120, and 240 minutes after ingestion of standard meal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adil E Bharucha, MBBS, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [13C]-Spirulina platensis and 99mTc sulfur colloid in people with Dyspepsia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Emptying Half Time Measured by Scintigraphy (time frame: 4 hours after ingestion of standard meal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2013.