Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects

Helicobacter Pylori Sample Collection Protocol POST-THERAPY

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.

Study Overview

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

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): 13

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy
    • One (1) Location in Bologna, Italy
• United States
  • California
    • Mission Hills, California, United States, 91345
      • One (1) Location in California
  • New York
    • Great Neck, New York, United States, 11023
      • One (1) Location in Great Neck, New York
  • Ohio
    • Mentor, Ohio, United States, 44060
      • One (1) Location in Ohio
  • Texas
    • Houston, Texas, United States, 77030
      • One (1) Location in Houston, Texas

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 are evaluated for H. pylori infectious status prior to eligibility. Evaluation includes use of a diagnostic H. pylori test, such as, an FDA cleared UBT or an FDA cleared Fecal Stool Antigen. Infectious status must be determined positive for H. pylori for subject eligibility.

Eligible subjects are undergoing EGD with biopsy for H. pylori infectious status after completion of therapy

Description

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 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 14, 2018
• Study Completion (ACTUAL): May 14, 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): February 7, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• 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: POST-TREAT Z001

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