Helicobacter Pylori Infection
Conditions
Brief summary
The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori infection in adult patients and its results will be compared to biopsy results.
Detailed description
Patients undergoing esophagogastroduodenoscopy (EGD) for initial diagnosis of H.pylori infection or post therapy confirmation of eradication will be eligible to participate in the trial. Two sets of biopsies will be taken: one set for histological analysis and one set for rapid urease test (RUT) analysis. The two results will be used as a gold standard composite score in determining the presence of H.pylori bacteria in the stomach. The Urea Breath Test (UBT) using the Exalenz Dual Mode BreathID Hp System will also be performed within a week of the biopsy. The outcome of the UBT will be compared to composite score of the biopsy and the accuracy of the UBT will be evaluated. The UBT will be performed using breath collection bags, where the subject will be asked to breathe into the bags before and after ingestion of the 13C-labelled urea.
Interventions
DEVICEDual Mode BreathID Hp System
The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device
Sponsors
Meridian Bioscience, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years of age. * Have the ability and willingness to sign the Informed Consent Form. * Present with clinical indication of H. pylori and a candidate for upper endoscopy For Initial Diagnosis arm: • Symptomatic patients naïve to H.pylori treatment in the past 18 months For Post-Therapy arm: * Documented biopsy with positive outcome prior to eradication therapy (including method of determination) * Documented eradication therapy within the past 6 months and completed at least 6 weeks prior to UBT
Exclusion criteria
* Participation in other interventional trials. * Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test. * PPI or H2 blockers within two (2) weeks prior to breath test. * Pregnant or breastfeeding women. * Allergy to test substrates. * Patient did not fast for the hour prior to the UBT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy | 9 months | Overall Agreement of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result |
| Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy | 9 months | Sensitivity of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result |
| Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy | 9 months | Specificity of urea breath test with Dual Mode Breath Hp System in accurately detecting lack of presence of H.pylori infection as compared to composite biopsy result |
Countries
Israel, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Initial Diagnosis Subjects Patients with clinical indication for H.pylori infection
Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device | 196 |
| Post Therapy Subjects Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months
Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device | 76 |
| Total | 272 |
Baseline characteristics
| Characteristic | Initial Diagnosis Subjects | Post Therapy Subjects | Total |
|---|---|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 14.94 | 49.0 years STANDARD_DEVIATION 15.53 | 48.64 years STANDARD_DEVIATION 15.11 |
| Sex: Female, Male Female | 116 Participants | 48 Participants | 164 Participants |
| Sex: Female, Male Male | 80 Participants | 28 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 203 | 1 / 79 |
| serious Total, serious adverse events | 0 / 203 | 0 / 79 |
Outcome results
Primary
Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy
Overall Agreement of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result
Time frame: 9 months
Population: According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results (composite reference standard), the subject is considered unevaluable and thus not included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Diagnosis Subjects | Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy | 98.33 Percent overall agreement |
| Post Therapy Subjects | Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy | 100 Percent overall agreement |
Primary
Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy
Sensitivity of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result
Time frame: 9 months
Population: According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results (composite reference standard), the subject is considered unevaluable and thus not included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Diagnosis Subjects | Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy | 98.32 Percent positive agreement |
| Post Therapy Subjects | Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy | 98.53 Percent positive agreement |
Primary
Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy
Specificity of urea breath test with Dual Mode Breath Hp System in accurately detecting lack of presence of H.pylori infection as compared to composite biopsy result
Time frame: 9 months
Population: According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results (composite reference standard), the subject is considered unevaluable and thus not included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Diagnosis Subjects | Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy | 97.9 Percent negative agreement |
| Post Therapy Subjects | Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy | 100 Percent negative agreement |