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NCT Number: NCT06306963

Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias

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.

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Key information

Conditions

Gastric Antral Vascular Ectasia Angiodysplasia Cardiovascular Diseases Chronic Disease Chronic Kidney Disease Cirrhosis Digestive System Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Gastrointestinal Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Stomach Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Taylor N Hines

CONTACT

[email protected]

507-538-9959

Xiao Jing Wang, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gastric Emptying Breath Test

Diagnostic 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.

Other names: Gastric motor function testing

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. GEBT Breath Test

    Time frame: 6 Hours

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Taylor N Hines

CONTACT

[email protected]

507-538-9959

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Cairn Diagnostics

Registry information

Acronym: GAVE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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