Specimen Collection Study for H. Pylori Testing

Completed

• Conditions: Helicobacter Infections

• Registration Number: NCT02970110
• Lead Sponsor: Biomerica

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-17
• Study First Posted: 2016-11-21
• Study Start: 2017-02-27
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Non-invasive collection procedure	1 year	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.

Trial Locations

Locations (4)

University of Southern California; 🇺🇸 Los Angeles, California, United States

Medley Research Associates; 🇺🇸 Medley, Florida, United States

Del Sol Research Management, Inc.; 🇺🇸 Tucson, Arizona, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States