Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects

Completed

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

• Registration Number: NCT03060733
• Lead Sponsor: DiaSorin Inc.

Brief Summary

The primary objective is to obtain stool samples from post-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: 2018-05-14
• Study Completion: 2018-05-14
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Adult ≥ 22 years, either gender
• Subject previously diagnosed with H. pylori infection
• Subject received and completed FDA approved treatment option
• Minimum of 4 weeks to one year has lapsed after completion of FDA approved treatment option
• Subject with a post therapy positive result from a FDA cleared UBT or FDA cleared Fecal Antigen Test
• Subject will undergo EGD and gastric biopsy as part of routine care to measure H. pylori post-therapy response
• 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 occurred ≤ 7 days prior to stool collection
• Willing and able to sign the IRB approved Informed Consent form for this study project

Exclusion Criteria

• Subject with current severe H. pylori infection
• Subject ingested compounds that may interfere with detecting of H. pylori, e.g. 4 weeks for antibiotics and 2 weeks for Bismuth preparations or proton pump inhibitors prior to collection
• 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 (5)

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

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

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

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

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