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

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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Other: Breath Test Collection bags

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 193
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Digestive Disease Associates, PA
    • Chevy Chase, Maryland, United States, 20815
      • Metropolitan Gastroenterology Group
  • Michigan
    • Detroit, Michigan, United States, 48377
      • Henry Ford Health System
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564
      • Digestive Health Care
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Hospital
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Clinical Research Solutions
  • Texas
    • Houston, Texas, United States, 77011
      • JM Research
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Bon Secours Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Initial Diagnosis Cohort; Subjects with clinical indication of H.pylori infection will undergo breath test compared to routine clinical standard of care- endoscopy	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; Other Names: IDKit Two

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Meridian Bioscience, Inc.
• Investigators: Study Director: Melina Arazy, M.D., VP of clinical affairs, Exalenz

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: December 5, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 12, 2013

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: H.Pylori
• Other Study ID Numbers: DM-MPBA-0813