Chronic Kidney Disease, Cirrhosis, Gastric Antral Vascular Ectasia
Conditions
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.
Interventions
DIAGNOSTIC_TESTGastric 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.
Sponsors
Mayo Clinic
Cairn Diagnostics
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nepean Dyspepsia Index | 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. |
| Abridged Bowel Disease Questionnaire | 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. |
| Leuven Postprandial Distress Scale | 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. |
| Bowel Disease Screen Questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| GEBT Breath Test | 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. |
Countries
United States
Contacts
CONTACTTaylor N Hines
PRINCIPAL_INVESTIGATORXiao Jing Wang, MD
Mayo Clinic
Outcome results
None listed