Specimen Collection Study for H. Pylori Testing

NCT02970110 | Completed

• 1 other identifier: HPY-COL-001
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 4

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.

Conditions

Helicobacter Infections

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biomerica: lead

Study Sites (4)

Del Sol Research Management, Inc.

Tucson, Arizona, 85712, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Medley Research Associates

Medley, Florida, 33166, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212-1610, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimen

MeSH Terms

Conditions

Helicobacter Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• James R Buxbaum, M.D.

  University of Southern California, Los Angeles County Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 21, 2016
• Study Start: February 27, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)