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

Phase 3

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Other: Breath Test Collection bags

• Registration Number: NCT02010112
• Lead Sponsor: Meridian Bioscience, Inc.

Brief 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.

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 Timeline

• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-12
• Study Start: 2014-01
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Initial Diagnosis Cohort	Breath Test Collection bags	Subjects with clinical indication of H.pylori infection will undergo breath test compared to routine clinical standard of care- endoscopy

Primary Outcome Measures

Name	Time	Method
overall percent agreement	21 days	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.

Secondary Outcome Measures

Name	Time	Method
overall percent agreement	21 days	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

Trial Locations

Locations (9)

Metropolitan Gastroenterology Group; 🇺🇸 Chevy Chase, Maryland, United States

Clinical Research Solutions; 🇺🇸 Jackson, Tennessee, United States

Digestive Disease Associates, PA; 🇺🇸 Baltimore, Maryland, United States

Montefiore Hospital; 🇺🇸 Bronx, New York, United States

Omega Medical Research; 🇺🇸 Warwick, Rhode Island, United States

JM Research; 🇺🇸 Houston, Texas, United States

Digestive Health Care; 🇺🇸 Ocean Springs, Mississippi, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Bon Secours Health System; 🇺🇸 Richmond, Virginia, United States