Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gastric Emptying Breath Test.
- Who it may be relevant to
- Registry conditions: Gastric Antral Vascular Ectasia, Cirrhosis, Chronic Kidney Disease. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test 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
Primary outcome measures
- 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]
Secondary outcome measures (1)
- GEBT Breath Test [Time frame: 6 Hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Mayo Clinic — Rochester
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. PMID 18406670
Identifiers
NCT: NCT06306963 · 23-004669