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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Initial Diagnosis Cohort

Subjects with clinical indication of H.pylori infection will undergo breath test compared to routine clinical standard of care- endoscopy

Group Type EXPERIMENTAL

Breath Test Collection bags

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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IDKit Two

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No