Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06306963

Conditions

Gastric Antral Vascular Ectasia

Cirrhosis

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Gastric Emptying Breath Test

Study Details

Brief 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. By participating in this study, you will help us learn how often these symptoms occur and how they relate to stomach functioning.

Conditions

Gastric Antral Vascular Ectasia

Cirrhosis

Chronic Kidney Disease

Study ID

NCT06306963

Start date

Mar 22, 2024

Status verified date

Feb, 2026

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Gastric Emptying Breath Test

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.

Primary outcome measure

  • Nepean Dyspepsia Index [ Time Frame: baseline ]
  • Abridged Bowel Disease Questionnaire [ Time Frame: baseline ]
  • Leuven Postprandial Distress Scale [ Time Frame: baseline ]
  • Bowel Disease Screen Questionnaire [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Taylor N Hines

507-538-9959hines.taylor@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Taylor N Hines

507-538-9959hines.taylor@mayo.edu

Principal Investigator:

Xiao Jing Wang, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 4, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.