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

Not Applicable

Completed

• Conditions: Suspicion of Being Infected With H.Pylori
• Interventions: Device: Modified BreathID

• Registration Number: NCT01650831
• Lead Sponsor: Meridian Bioscience, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-26
• Study Start: 2012-10
• Primary Completion: 2012-11
• Study Completion: 2013-01
• Results First Submitted: 2013-05-28
• Results First Submitted QC: 2013-07-30
• Results First Posted: 2013-09-02
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinical Suspicion of Hpylori	Modified BreathID	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

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori	25 minutes	The marketed (cleared) BreathID device and the investigational modified new generation BreathID device will measure simultaneously before (baseline) and after ingestion of substrate. The subject will be connected to both devices. The maximum time of measurement is 25 minutes.
Positive/Negative for H.Pylori With Cleared BreathID	1 hour	The amount of subjects that produced positive/negative results with cleared BreathID device
Positive/Negative for H.Pylori With Modified BreathID	1 hour	The amount of subjects that produced positive/negative results for H.pylori with modified BreathID

Trial Locations

Locations (1)

Unimed Center; 🇺🇸 East Brunswick, New Jersey, United States