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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02970110
Other study ID # HPY-COL-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 27, 2017
Est. completion date March 1, 2020

Study information

Verified date March 2022
Source Biomerica
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 21 Years to 75 Years
Eligibility Inclusion Criteria: - Aged 21 and to 75 years. - Able to read, speak, and understand English or have access to a translator in subject's native language. - Patients without prior H. pylori eradication treatment. - Currently not on proton pump inhibitors, antibiotics or bismuth - Discontinuation at least 2 weeks prior to endoscopy and specimen collection. - Present with signs and symptoms of dyspepsia [e.g. upper abdominal discomfort or pain] - Undergo gastric biopsies as part of routine care - Physician able to provide histology and rapid urease result on biopsy specimens. Exclusion Criteria: - Aged less than 21 years old or older than 75 years - Unable to provide consent. - Patients with a history of prior H. pylori eradication therapy. - Currently on proton pump inhibitors, antibiotics or bismuth and cannot or will not discontinue - Previous upper gastrointestinal surgery, such as bariatric surgery, Nissen fundoplication, or Roux-en-Y. - Any unstable or poorly-controlled medical or psychiatric condition.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Southern California Los Angeles California
United States Medley Research Associates Medley Florida
United States Vanderbilt University Medical Center Nashville Tennessee
United States Del Sol Research Management, Inc. Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Biomerica

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Non-invasive collection procedure This study is designed to collect specimens to supplement repository specimens for product validation purposes. The endoscopy results and specimens will be used in a future clinical trial of a non-invasive in vitro diagnostic assay for the detection of H. pylori antigen. institutional review board approval is sought in order to be able to use human specimens for validation of in vitro diagnostics. 1 year
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