Last updated on July 2017

Specimen Collection Study for H. Pylori Testing


Brief description of study

The objective of this study is to acquire human specimens from subjects undergoing routine endoscopy with gastric biopsy for the diagnosis of active H. pylori infection.

Detailed Study Description

This is a prospective study designed to acquire and bank human specimens from subjects who are scheduled for routine upper endoscopy for symptoms such as dyspepsia. This study will be conducted at a minimum of 2 sites in the United States. Investigator sites will enroll prospective subjects who meet the inclusion / exclusion criteria. A case report form (CRF) provided by the sponsor will be used to capture basic demographic information (DOB, age, gender, race/ethnicity), medication history, and related clinical information. The CRFs will also record the results of the following tests performed with the gastric biopsy tissue specimens: histology and rapid urease test (RUT).

Clinical Study Identifier: NCT02970110

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James L Buxbaum, MD

University of Southern California
Los Angeles, CA United States
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Douglas R Morgan, M.D., M.P.H.

Vanderbilt University Medical Center
Nashville, TN United States
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