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| Name | Class |
|---|---|
| Cairn Diagnostics | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| GEBT Breath Test | 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. | 6 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taylor N Hines | Contact | 507-538-9959 | hines.taylor@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Xiao Jing Wang, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18406670 | Background | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D020252 | Gastric Antral Vascular Ectasia |
| D005355 | Fibrosis |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D016888 | Angiodysplasia |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |