Helicobacter Pylori Sample Collection Protocol Pre Therapy Subjects

Weight Loss Clinical Trial

Official title:

Helicobacter Pylori Sample Collection Protocol PRE-THERAPY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060746
• Other study ID #: PRE-TREAT A001
• Status: Completed
• Start date: February 14, 2017
• Est. completion date: May 3, 2018

Study information

• Verified date: February 2019
• Source: DiaSorin Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: May 3, 2018
• Est. primary completion date: May 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Anorexia
• Bloating
• Gastric Ulcer
• Helicobacter Pylori Infection
• Loss of Appetite
• Nausea
• Stomach Ulcer
• Ulcer
• Weight Loss

Intervention

Other:
• Newly Diagnosed
Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample

Locations

Country	Name	City	State
Italy	One (1) Location in Bologna, Italy	Bologna
United States	One (1) Location in North Carolina	Asheville	North Carolina
United States	One (1) Location in Virginia	Chesapeake	Virginia
United States	One (1) Location in Great Neck, New York	Great Neck	New York
United States	One (1) Location in Greenville, South Carolina	Greenville	South Carolina
United States	One (1) Location in Houston, Texas	Houston	Texas
United States	One (1) Location in Ohio	Mentor	Ohio
United States	One (1) Location in Arizonia	Mesa	Arizona
United States	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 Missouri	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
DiaSorin Inc.	ICON Clinical Research

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori Stool Collection	In vitro diagnostic (IVD) device performance	Through Study Completion, an average of 1 year