Specimen Collection Study for H. Pylori Testing

Specimen Collection Study for H. Pylori Testing in Patients With Dyspepsia

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Infections

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 Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Del Sol Research Management, Inc.
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Florida
    • Medley, Florida, United States, 33166
      • Medley Research Associates
  • Tennessee
    • Nashville, Tennessee, United States, 37212-1610
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will consist of subjects scheduled for routine upper endoscopy for upper gastrointestinal tract symptoms such as dyspepsia. All prospective subjects must be off of proton-pump inhibitors, antibiotics, and bismuth for at least 2 weeks prior to submission of the stool specimen and undergoing endoscopy.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Biomerica
• Investigators: Principal Investigator: James R Buxbaum, M.D., University of Southern California, Los Angeles County Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2017
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimate): November 21, 2016

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Helicobacter Infections
• Other Study ID Numbers: HPY-COL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Demographics including age, gender, geographical location, histology and RUT results collected in this study will be shared with researchers involved with a future evaluation of an in vitro diagnostic device product in development at Biomerica.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No