Gastric Antral Vascular EctasiaGAVENCT06306963
Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
An observational study of Gastric Antral Vascular Ectasia and Cirrhosis, run by Mayo Clinic at 1 site in United States.
Trial summary
The researchers are trying to find out more about Gastric Antral Vascular Ectasia (GAVE). This is a condition that affects the blood vessels in the stomach, leading to their enlargement and possible bleeding. It can also cause symptoms such as abdominal pain and nausea. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Antral Vascular Ectasia, Cirrhosis, Chronic Kidney Disease
- What is being tested?
- Gastric Emptying Breath Test
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone an endoscopy and found to have GAVE will be included. Patients with underlying cirrhosis or chronic kidney disease and GAVE in comparison to control patients with cirrhosis or chronic kidney disease and no GAVE.
Who may be able to join
- Patients >18 years of age with endoscopic evidence of Gastric Antral Vascular Ectasia.
- Willingness to participate in the study
- Capacity to provide informed consent.
- No evidence of organic, systemic, or metabolic disease (e.g. diabetes mellitus) to explain the symptoms on routine investigations
Who cannot join
- Patients with transfusion dependent blood loss.
- Patients with severe decompensated liver disease.
- Patients with end stage renal disease.
- Presence of other diseases (structural or metabolic) which could interfere with interpretation of the study results.
- Pregnant or lactating women.
- Patients who have not had a CBC and differential blood draw completed within the last six months.
- Current heavy alcohol use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Taylor N Hines, 507-538-9959, hines.taylor@mayo.edu
Xiao Jing Wang, MD
About this study
The researchers are trying to find out more about Gastric Antral Vascular Ectasia (GAVE). This is a condition that affects the blood vessels in the stomach, leading to their enlargement and possible bleeding. It can also cause symptoms such as abdominal pain and nausea. By participating in this study, you will help us learn how often these symptoms occur and how they relate to stomach functioning.
- Being tested
- Gastric Emptying Breath Test
- Medical subject headings
- Gastric Antral Vascular Ectasia, Fibrosis, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric Emptying Breath TestDiagnostic test
Also called Gastric motor function testing
13C-Spirulina GEBT (Cairn Diagnostics) is non-radioactive, non-invasive breath based test validated against scintigraphy for the measurement of gastric emptying. Patients will be mailed test kits to be done in their homes remotely along with telehealth assistance from the study team. After overnight fast and providing duplicate pre-meal breath samples, the patient consumes 27 grams of re-hydrated, precisely formulated, pasteurized scrambled egg mix containing a dose of 43 mg of 13C (provided by approximately 100 mg of 13C-Spirulina), 6 saltine crackers and 6 ounces (180 mL) of potable water. The caloric value of the meal is approximately 230 kCal.Patient will provide breath samples into provided glass tubes before and after test meal administration which are then mailed back to a central laboratory for analysis by gas isotope ratio mass spectrometry.
| Study group | Role | What they receive |
|---|---|---|
| Cirrhosis or Chronic Kidney Disease With Gastric Antral Vascular Ectasia | Patients with Gastric Antral Vascular Ectasia with cirrhosis or chronic kidney disease will undergo a gastric emptying breath test. This test is designed to show how quickly the stomach empties solids by measuring labeled carbon dioxide in a patient's breath. Receives: Diagnostic Test: Gastric Emptying Breath Test | |
| Cirrhosis or Chronic Kidney Disease Without Gastric Antral Vascular Ectasia | Patients without Gastric Antral Vascular Ectasia with cirrhosis or chronic kidney disease will undergo a gastric emptying breath test. This test is designed to show how quickly the stomach empties solids by measuring labeled carbon dioxide in a patient's breath. Receives: Diagnostic Test: Gastric Emptying Breath Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nepean Dyspepsia Index
The Nepean Dyspepsia Index is a 10-item questionnaire that measures dyspepsia problems. Each item is scored from 1-5. 1 = Not at all, 5 = Extremely. Total scores range from 10 - 50, lower scores indicate less dyspepsia problems, higher scores indicate more dyspepsia problems.
Measured: baseline
Abridged Bowel Disease Questionnaire
The Abridged Bowel Disease Questionnaire is a 14-item questionnaire that measures Bowel Disease symptoms. Each item is scored as yes or no. Scores answering yes indicate more bowel disease, and scores answering no indicate less or no bowel disease.
Measured: baseline
Leuven Postprandial Distress Scale
The Leuven Postprandial Distress Scale is an 8-item questionnaire that measures symptoms of dyspepsia. Each item is scored from 1-5. 1 = Absent, 5 = very severe. Total scores range from 0-40 Lower scores indicate less or no symptoms of dyspepsia, higher scores indicate more symptoms of dyspepsia.
Measured: baseline
Bowel Disease Screen Questionnaire
the Bowel Disease Screen Questionnaire is a 20 item questionnaire that measures stomach and bowel disease symptoms. Each item is scored from 1-5. 1=not at all, 5=Extremely. Total scores range from 10-95.
Measured: Baseline
Secondary outcomes (1)
GEBT Breath Test
The C-Spirulina Gastric Emptying Breath Test is a non-radioactive, Non-invasive test for measurement of the rate in gastric emptying in adults by measuring the C-13 levels in the breath.
Measured: 6 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start22 Mar 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric Antral Vascular EctasiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Cairn Diagnostics
- Responsible party
- Principal investigator, Xiao Jing (Iris) Wang, Mayo Clinic
- Investigators
- Xiao Jing Wang, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306963
- Sponsor's protocol ID
- 23-004669
- Acronym
- GAVE
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szarka LA, Camilleri M, Vella A, Burton D, Baxter K, Simonson J, Zinsmeister AR. A stable isotope breath test with a standard meal for abnormal gastric emptying of solids in the clinic and in research. Clin Gastroenterol Hepatol. 2008 Jun;6(6):635-643.e1. doi: 10.1016/j.cgh.2008.01.009. Epub 2008 Apr 14.
PubMed 18406670
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
- ClinicalTrials.gov ID
- NCT06306963
- Acronym / sponsor ID
- GAVE / 23-004669
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Cairn Diagnostics
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are trying to find out more about Gastric Antral Vascular Ectasia (GAVE). This is a condition that affects the blood vessels in the stomach, leading to their enlargement and possible bleeding. It can also cause symptoms such as abdominal pain and nausea. By participating in this study, you will help us learn how often these symptoms occur and how they relate to stomach functioning.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cirrhosis or Chronic Kidney Disease With Gastric Antral Vascular Ectasia | – | Diagnostic Test: Gastric Emptying Breath TestPatients with Gastric Antral Vascular Ectasia with cirrhosis or chronic kidney disease will undergo a gastric emptying breath test. This test is designed to show how quickly the stomach empties solids by measuring labeled carbon dioxide in a patient's breath. |
| Cirrhosis or Chronic Kidney Disease Without Gastric Antral Vascular Ectasia | – | Diagnostic Test: Gastric Emptying Breath TestPatients without Gastric Antral Vascular Ectasia with cirrhosis or chronic kidney disease will undergo a gastric emptying breath test. This test is designed to show how quickly the stomach empties solids by measuring labeled carbon dioxide in a patient's breath. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone an endoscopy and found to have GAVE will be included. Patients with underlying cirrhosis or chronic kidney disease and GAVE in comparison to control patients with cirrhosis or chronic kidney disease and no GAVE.
Key inclusion criteria (4 listed)
- Patients >18 years of age with endoscopic evidence of Gastric Antral Vascular Ectasia.
- Willingness to participate in the study
- Capacity to provide informed consent.
- No evidence of organic, systemic, or metabolic disease (e.g. diabetes mellitus) to explain the symptoms on routine investigations
Key exclusion criteria (7 listed)
- Patients with transfusion dependent blood loss.
- Patients with severe decompensated liver disease.
- Patients with end stage renal disease.
- Presence of other diseases (structural or metabolic) which could interfere with interpretation of the study results.
- Pregnant or lactating women.
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 |
|---|---|---|
| Gastric Emptying Breath TestAlso: Gastric motor function testing13C-Spirulina GEBT (Cairn Diagnostics) is non-radioactive, non-invasive breath based test validated against scintigraphy for the measurement of gastric emptying. Patients will be mailed test kits to be done in their homes remotely along with telehealth assistance from the study team. After overnight fast and providing duplicate pre-meal breath samples, the patient consumes 27 grams of re-hydrated, precisely formulated, pasteurized scrambled egg mix containing a dose of 43 mg of 13C (provided by approximately 100 mg of 13C-Spirulina), 6 saltine crackers and 6 ounces (180 mL) of potable water. The caloric value of the meal is approximately 230 kCal.Patient will provide breath samples into provided glass tubes before and after test meal administration which are then mailed back to a central laboratory for analysis by gas isotope ratio mass spectrometry. | Diagnostic test | Cirrhosis or Chronic Kidney Disease With Gastric Antral Vascular Ectasia, Cirrhosis or Chronic Kidney Disease Without Gastric Antral Vascular Ectasia |
Primary outcome
Nepean Dyspepsia Index
Time frame: baseline
The Nepean Dyspepsia Index is a 10-item questionnaire that measures dyspepsia problems. Each item is scored from 1-5. 1 = Not at all, 5 = Extremely. Total scores range from 10 - 50, lower scores indicate less dyspepsia problems, higher scores indicate more dyspepsia problems.
Abridged Bowel Disease Questionnaire
Time frame: baseline
The Abridged Bowel Disease Questionnaire is a 14-item questionnaire that measures Bowel Disease symptoms. Each item is scored as yes or no. Scores answering yes indicate more bowel disease, and scores answering no indicate less or no bowel disease.
Leuven Postprandial Distress Scale
Time frame: baseline
The Leuven Postprandial Distress Scale is an 8-item questionnaire that measures symptoms of dyspepsia. Each item is scored from 1-5. 1 = Absent, 5 = very severe. Total scores range from 0-40 Lower scores indicate less or no symptoms of dyspepsia, higher scores indicate more symptoms of dyspepsia.
Bowel Disease Screen Questionnaire
Time frame: Baseline
the Bowel Disease Screen Questionnaire is a 20 item questionnaire that measures stomach and bowel disease symptoms. Each item is scored from 1-5. 1=not at all, 5=Extremely. Total scores range from 10-95.
1 secondary outcome
GEBT Breath Test
Time frame: 6 Hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 18406670Szarka LA, Camilleri M, Vella A, Burton D, Baxter K, Simonson J, Zinsmeister AR. A stable isotope breath test with a standard meal for abnormal gastric emptying of solids in the clinic and in research. Clin Gastroenterol Hepatol. 2008 Jun;6(6):635-643.e1. doi: 10.1016/j.cgh.2008.01.009. Epub 2008 Apr 14.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Gastric Antral Vascular Ectasia
Recruiting
Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)
Gastric Antral Vascular Ectasia
Enrolling by invitation
Correlations of the Microvascular Abnormalities on NVC (Nail Fold Video Capillaroscopy) and GAVE (Gastric Antral Vascular Ectasia) as Seen on EGD
Gastric Antral Vascular Ectasia
Not yet recruitingObservational study
Study on the Efficacy of Endoscopic Radiofrequency Treatment in Reducing the Need for Blood Transfusions in GAVE
GAVE - Gastric Antral Vascular Ectasia
Not yet recruiting
Thalidomide Versus Argon Plasma Coagulation in Gastric Antral Vascular Ectasia(GAVE)-Related Anaemia in Cirrhosis (TAG Trial)
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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.
Xiao Jing Wang, MD 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?
An observational study of Gastric Antral Vascular Ectasia and Cirrhosis, 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 4 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taylor N Hines (507-538-9959, hines.taylor@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nepean Dyspepsia Index (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06306963, which also lists 1 linked publication.
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 26 Oct 2026.