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

NCT06306963 | Recruiting

• 1 other identifier: 23-004669
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline

Secondary Outcomes (1)

• GEBT Breath Test

  6 Hours

Study Arms (2)

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.

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.

Diagnostic Test: Gastric Emptying Breath Test

Interventions

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.

Also known as: Gastric motor function testing

Cirrhosis or Chronic Kidney Disease With Gastric Antral Vascular Ectasia; Cirrhosis or Chronic Kidney Disease Without Gastric Antral Vascular Ectasia

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Cairn Diagnostics: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 18406670 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Gastric Antral Vascular Ectasia; Fibrosis; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Xiao Jing Wang, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taylor N Hines

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 12, 2024
• Study Start: March 22, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)