Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori

Helicobacter Pylori Infection Clinical Trial

Official title:

Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the Dual Mode BreathID® Hp System Compared to Congruent Biopsy Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010112
• Other study ID #: DM-MPBA-0813
• Status: Completed
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: February 2015

Study information

• Verified date: December 2022
• Source: Meridian Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.

Description:

This study will validate a breath collection method by comparing a newly developed breath test kit, IDkit:Hp™ TWO using breath collection bags, to congruent biopsy results (a composite reference standard by analyzing specimens with microbial culture, histological examination and rapid urease test- RUT) in detecting H.Pylori

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Present with clinical indication of H. pylori and candidate for upper endoscopy

• Have the ability and willingness to sign the Informed Consent Form for initial diagnosis cohort

• Naive to treatment in the past 18 months

• No known H.pylori status (no conclusive test results within last 6 months)

Exclusion Criteria:

• Participation in other interventional trials

• Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test

• PPI (proton pump inhibitors) or H2 blockers within two (2) weeks prior to breath test

• Pregnant or breastfeeding women

• Allergy to test substrates

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Other:
• Breath Test Collection bags
Breath Collection bags will be used to collect breath of subjects before and after ingestion of 13-C breath test substrate

Locations

Country	Name	City	State
United States	Digestive Disease Associates, PA	Baltimore	Maryland
United States	Montefiore Hospital	Bronx	New York
United States	Metropolitan Gastroenterology Group	Chevy Chase	Maryland
United States	Henry Ford Health System	Detroit	Michigan
United States	JM Research	Houston	Texas
United States	Clinical Research Solutions	Jackson	Tennessee
United States	Digestive Health Care	Ocean Springs	Mississippi
United States	Bon Secours Health System	Richmond	Virginia
United States	Omega Medical Research	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Meridian Bioscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall percent agreement	The primary study endpoint is the performance measure (overall percent agreement) in initial diagnosis (presence/ absence of H.pylori) between biopsy results and bag mode breath test.	21 days
Secondary	overall percent agreement	The performance measure (overall percent agreement) in post-therapy diagnosis (presence/ absence of H.pylori) between the Dual Mode BreathID® Hp System when using only one pair of IDkit:Hp™ TWO breath collection bags measured within 9 days and congruent biopsy results	21 days