Helicobacter Pylori Sample Collection Protocol Pre Therapy Subjects

Helicobacter Pylori Sample Collection Protocol PRE-THERAPY

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.

Study Overview

• Status: Completed
• Conditions: Nausea; Abdominal Pain; Weight Loss; Helicobacter Pylori Infection; Gastric Ulcer; Stomach Ulcer; Loss of Appetite; Bloating
• Intervention / Treatment: Other: Newly Diagnosed

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 Type: Observational
• Enrollment (Actual): 277

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy
    • One (1) Location in Bologna, Italy
• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • One (1) Location in Arizonia
  • California
    • Mission Hills, California, United States, 91345
      • One (1) Location in Mission Hills, California
    • Oxnard, California, United States, 93030
      • One (1) Location in Oxnard, California
  • Florida
    • Palm Harbor, Florida, United States, 34684
      • One (1) Location in Florida
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • One (1) Location in Missouri
  • New York
    • Great Neck, New York, United States, 11023
      • One (1) Location in Great Neck, New York
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • One (1) Location in North Carolina
  • Ohio
    • Mentor, Ohio, United States, 44060
      • One (1) Location in Ohio
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • One (1) Location in Greenville, South Carolina
  • Texas
    • Houston, Texas, United States, 77030
      • One (1) Location in Houston, Texas
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • One (1) Location in Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing EGD with biopsy for H. pylori diagnosis

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helicobacter pylori Stool Collection	In vitro diagnostic (IVD) device performance	Through Study Completion, an average of 1 year

Collaborators and Investigators

• Sponsor: DiaSorin Inc.
• Collaborators: ICON Clinical Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 14, 2017
• Primary Completion (ACTUAL): May 3, 2018
• Study Completion (ACTUAL): May 3, 2018

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 17, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Stomach Diseases; Body Weight; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Body Weight Changes; Anorexia; Ulcer; Weight Loss; Abdominal Pain; Stomach Ulcer
• Other Study ID Numbers: PRE-TREAT A001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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