Helicobacter Pylori Sample Collection Protocol Pre Therapy Subjects

Completed

• Conditions: Helicobacter Pylori Infection; Nausea; Abdominal Pain; Weight Loss; Loss of Appetite; Stomach Ulcer; Bloating; Gastric Ulcer

• Registration Number: NCT03060746
• Lead Sponsor: DiaSorin Inc.

Brief Summary

The primary objective is to obtain stool samples from pre-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.

Detailed Description

Stools will be collected and tested, at a later date, in a clinical performance study with an investigational H. pylori antigen assay. This study will be coordinated by the Sponsor.

Study Timeline

• Study Start: 2017-02-14
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-17
• Study First Posted: 2017-02-23
• Primary Completion: 2018-05-03
• Study Completion: 2018-05-03
• Status Verified: 2019-02
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 277

Inclusion Criteria

• Adult ≥ 22 years, either gender
• Subject is symptomatic showing signs and symptoms of gastritis
• Subject is not under evaluation for post-therapy follow up diagnosis
• Subject is already undergoing upper EGD and obtaining a gastric biopsy as part of routine care for H. pylori diagnosing
• Biopsy is obtained from antrum and/or corpus and is tested by CRM
• At least two of the three CRM tests are performed
• Subject whose EGD with biopsy procedure occurred ≤ 7 days prior to stool collection
• Willing and able to sign the IRB approved Informed Consent form for this project, or able to provide Informed Consent in accordance with 21 CFR 50 Subpart B

Exclusion Criteria

• Any subject that does not meet the inclusion criteria
• Subject with current severe H. pylori infection
• Subject ingested compounds that may interfere with detection of H. pylori e.g. 4 weeks for all antibiotics, 2 weeks for Bismuth preparations or proton pump inhibitors prior to EGD/collection
• Subject recently tested, less than 3 months and knowledge of H. pylori absence
• Subject tested, less than one year and knowledge of H. pylori presence but NOT undergone prescribed treatment
• Pregnant or lactating
• Inability or unwilling to perform required study procedures
• Subject is unable or unwilling to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori Stool Collection	Through Study Completion, an average of 1 year	In vitro diagnostic (IVD) device performance

Trial Locations

Locations (12)

One (1) Location in Mission Hills, California; 🇺🇸 Mission Hills, California, United States

One (1) Location in Oxnard, California; 🇺🇸 Oxnard, California, United States

One (1) Location in Florida; 🇺🇸 Palm Harbor, Florida, United States

One (1) Location in Virginia; 🇺🇸 Chesapeake, Virginia, United States

One (1) Location in Bologna, Italy; 🇮🇹 Bologna, Italy

One (1) Location in Ohio; 🇺🇸 Mentor, Ohio, United States

One (1) Location in Greenville, South Carolina; 🇺🇸 Greenville, South Carolina, United States

One (1) Location in Arizonia; 🇺🇸 Mesa, Arizona, United States

One (1) Location in Houston, Texas; 🇺🇸 Houston, Texas, United States

One (1) Location in Great Neck, New York; 🇺🇸 Great Neck, New York, United States

One (1) Location in North Carolina; 🇺🇸 Asheville, North Carolina, United States

One (1) Location in Missouri; 🇺🇸 Saint Louis, Missouri, United States