Suspicion of Being Infected With H.Pylori
Conditions
Keywords
Helicobacter Pylori, 13C Urea Breath Test, BreathID
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.
Interventions
DEVICEModified BreathID
A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula
Sponsors
Meridian Bioscience, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Adult subjects with suspected infection of Helicobacter Pylori due to symptoms were offered to do the test on a walk- in basis were recruited. 113 Subjects were recruited in October and November 2012 in a private medical clinic.
Pre-assignment details
Subjects with prior knowledge of Helicobacter Pylori infection or taking proton pump inhibitors within the two week period before the test, were not included.Only one test per subject was done.
Participants by arm
| Arm | Count |
|---|---|
| Clinical Suspicion of Hpylori 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
Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula | 113 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen failure | 1 |
Baseline characteristics
| Characteristic | Clinical Suspicion of Hpylori |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 23 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants |
| Age, Continuous | 49.6 years STANDARD_DEVIATION 16.71 |
| Region of Enrollment United States | 113 participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 113 |
| serious Total, serious adverse events | 0 / 113 |
Outcome results
Primary
Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori
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.
Time frame: 25 minutes
Population: Only subjects that had no recent knowledge of existing H.pylori infection and who met all protocol criteria and had no major protocol deviations, were included in the final analysis set (PP-per protocol).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinical Suspicion of Hpylori | Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori | Positive agreeement | 100 Percentage of participants |
| Clinical Suspicion of Hpylori | Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori | Negative agreement | 96.8 Percentage of participants |
Primary
Positive/Negative for H.Pylori With Cleared BreathID
The amount of subjects that produced positive/negative results with cleared BreathID device
Time frame: 1 hour
Population: Per protocol positive/negative when testing with marketed BreathID
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clinical Suspicion of Hpylori | Positive/Negative for H.Pylori With Cleared BreathID | 17 participants |
| Marketed BreathID Negative | Positive/Negative for H.Pylori With Cleared BreathID | 62 participants |
Primary
Positive/Negative for H.Pylori With Modified BreathID
The amount of subjects that produced positive/negative results for H.pylori with modified BreathID
Time frame: 1 hour
Population: Per protocol subjects tested with modified BreathID
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clinical Suspicion of Hpylori | Positive/Negative for H.Pylori With Modified BreathID | 19 participants |
| Marketed BreathID Negative | Positive/Negative for H.Pylori With Modified BreathID | 60 participants |