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

Conditions

• Chronic Kidney Disease
• Cirrhosis
• Gastric Antral Vascular Ectasia

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Mar 22, 2024

Status verified

Feb 2026

Primary completion

Sep 1, 2026

Completion

Sep 1, 2026

Study Design

Enrollment

30 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.

Primary Outcome Measure

Nepean Dyspepsia Index [ Time Frame: baseline ]

Central Contacts

• Taylor N Hines
  507-538-9959
  [email protected]

Locations (1)

Find similar trials in Rochester, MN

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