Show Equivalence of the Modified BreathID Compared to Currently Approved BreathID in H.Pylori Detection

Meridian Bioscience

Status: Completed

Conditions: Suspicion of Being Infected With H.Pylori

Treatments: Device: Modified BreathID

Study type: Interventional

Funder types: Industry

Identifiers

NCT01650831

HP-MBI-0212

Details and patient eligibility

About

The purpose of this study is to confirm equivalence of a new generation breath analyzer (Modified BreathID) in its ability to detect H. pylori compared to the currently approved BreathID® System.

Full description

The ¹³C-Urea Breath Test (UBT) is a non-invasive test for detecting the presence of Helicobacter pylori (H. pylori) infection by the organism's urease activity. In the presence of H. pylori, the ingestion of urea, labeled with the non-radioactive isotope 13C, results in production of labeled 13CO2, which can be quantified in expired breath. Each test is performed using a test kit consisting of a 13C-urea tablet and citrica powder to be dissolved in tap water ("13C-urea solution"). Before and after ingestion of the 13C-urea solution, samples of exhaled breath can be collected using a nasal cannula for real-time analysis and comparison to baseline concentrations. The patient's exhaled breath is analyzed and the ratio between 13CO2 and 12CO2 is computed. The patient is considered H. pylori positive when the difference between the ratios exceeds a predefined threshold (5 delta over baseline (DOB)). The current device marketed by Exalenz is large and costly. Exalenz has built a smaller, cheaper and more reliable new generation device for this application. Equivalence is being demonstrated in this study.

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be at least 18 years of age
2. Present with clinical indication of H. pylori
3. Have the ability and willingness to sign the Informed Consent Form-

Exclusion criteria

1. Current serious disease
2. Participation in other trials
3. Antibiotics and/or Bismuth preparations for four (4) weeks prior to test
4. PPI or H2 blockers for two (2) weeks prior to test
5. Childbearing or breastfeeding women
6. Based on opinion of investigator, subject should not be enrolled in this trial
7. Allergy to citrus juice
8. Post -eradication therapy for H. pylori

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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113 participants in 1 patient group

Clinical Suspicion of Hpylori

Active Comparator group

Description:

All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions

Treatment:

Device: Modified BreathID