This study evaluates the effect of consuming an item high in nitrates (beef broth) on the tissue of the esophagus in patients undergoing an upper endoscopy. Molecules found in food and throughout the body, such as nitrates that are found in beef broth, regulate stomach acidity and play a role in esophageal conditions. Studying samples of tissue taken from the esophagus for during an upper endoscopy in the laboratory may help doctors learn more about the effects of nitrates on the cells. Information gathered from this study may help researchers predict patients that are more at risk for developing certain diseases of the esophagus and better understand about conditions of the esophagus.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04642690.
PRIMARY OBJECTIVE:
I. To determine serum, saliva, and tissue levels of nitrates in patients with normal squamous epithelium, erosive esophagitis, non-dysplastic BE (NDBE), and BE with high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC).
II. To compare serum and tissue levels of IL-8 with varying levels of BE dysplasia and EAC.
III. To determine whether there is an association between nitrate levels and IL-8.
SECONDARY OBJECTIVE:
I. Compare serum and tissue levels of IL-8 from patients with NDBE that progressed to BE dysplasia or EAC compared to those without progression.
OUTLINE: This is an observational study.
Patients complete a questionnaire and undergo standard of care endoscopic procedure on study. Patients also undergo biopsy and collection of saliva and blood samples on study.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorCadman L. Leggett
