Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Conditions
Keywords
Helicobacter pylori
Brief summary
The purpose of this study is to compare between the POCone® to the UBiT®-IR300 in measuring 13CO2/12CO2 ratio in breath samples when used together with the BreathTek® UBT (urea breath test) Kit and the pUHR-CA web-based software program in identifying H. pylori infection in pediatric subjects.
Detailed description
The same patients will be tested on both the POCone® and UBiT®-IR300. If the patients test positive for H. pylori, they will be given eradication medication and brought back in for a re-test.
Interventions
OTHERPranactin citric solution
All patients were required to drink the pranactic citric solution to diagnose H.pylori.
Sponsors
Otsuka America Pharmaceutical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subject ages 3 to 1711/12 years. 2. Subject with upper gastrointestinal signs and symptoms (e.g., abdominal pain/discomfort, bloating, nausea, or vomiting, etc.) 3. Subject and/or parent/legal guardian is capable of giving assent or consent. 4. Subject is able to complete the urea breath test by investigator's assessment.
Exclusion criteria
1. Subject is hypersensitive to mannitol, citric acid and/or aspartame. 2. Previous diagnosis of phenylketonuria (PKU. 3. Subject with difficulty swallowing or who may be at high risk for aspiration due to medical or physical conditions. 4. Subjects with ongoing respiratory conditions or on bronchodilators that may compromise the collection of breath samples. 5. Subjects with severe chronic illness (e.g., Crohn's disease, leukemia, kidney diseases, etc.) 6. Administration of bismuth preparations (e.g., Pepto-Bismol®) at anytime within 14 days prior to the testing. 7. Administration of antibiotics (e.g., amoxicillin, tetracycline, metronidazole, clarithromycin, azithromycin, etc.) therapy at anytime within 14 days prior to the testing. 8. Administration of proton pump inhibitors (PPI; e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, pantoprazole, etc.) at anytime within 14 days prior to the testing. 9. Administration of Histamine H2 receptor antagonist (H2RA; e.g., ranitidine, cimetidine, famotidine, nizatidine, etc.) at anytime within 24 hours prior to the testing. 10. Treatment for eradication of H pylori within 28 days before testing or retesting. 11. Participation in a drug or device study within 30 days of testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between POCone and UBiT-IR300. | Baseline, Post Dose (15 min) | The study end-points are UHR values derived from DOB (delta over baseline) values obtained from the POCone and UBiT-IR300 (UHRP and UHRU, respectively) at Baseline and Post-Dose. Same patients will be tested on both the POCone and UBiT-IR300. Subjects fasted for at least 1 hr prior test. Each patient provided breath samples in 3 blue (Baseline) breath bags-labeled A B C. Subjects were given Pranactin-Citric solution (4oz) to drink, waited 15 min and collected 3 pink (post-dose) bags which were paired with the baseline bags in no particular order. Each pair was tested on both machines. The first two available pairs of UHR values were used for data analysis. The 3rd pair was used only if one of the first two samples did not produce a valid test result. DOB values were generated by the two instruments for each Baseline and Post Dose pair. UHR values were claculated based on the DOB values and the subject's anthropometric variables (age, gender, ehight and body weight). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Tested Positive/Negative for H. Pylori | Single Study Visit (1 hour of testing) | Qualified subjects from clinical sites underwent a standard urea breath test using the BreathTek UBT Kit. Breath samples were analyzed using both the POCone and the UBiT-IR300. DOB values from these two infrared spectrophotometers were converted to respective UHR values using pUHR-CA. The paired UHR values from each subject were evaluated for agreement. UHR values of \>10 µg/min were considered positive for H. pylori and UHR values of \<10 µg/min were considered negative for H. pylori. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BreathTek UBT Comparison of urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT-IR300. UBiT-IR300 is the FDA approved device. | 95 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not drink Pranactin Citric | 4 |
Baseline characteristics
| Characteristic | BreathTek UBT |
|---|---|
| Age, Categorical <=18 years | 95 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 10.5 years |
| Region of Enrollment United States | 95 Number of Participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 99 |
| serious Total, serious adverse events | 0 / 99 |
Outcome results
Primary
Agreement Between POCone and UBiT-IR300.
The study end-points are UHR values derived from DOB (delta over baseline) values obtained from the POCone and UBiT-IR300 (UHRP and UHRU, respectively) at Baseline and Post-Dose. Same patients will be tested on both the POCone and UBiT-IR300. Subjects fasted for at least 1 hr prior test. Each patient provided breath samples in 3 blue (Baseline) breath bags-labeled A B C. Subjects were given Pranactin-Citric solution (4oz) to drink, waited 15 min and collected 3 pink (post-dose) bags which were paired with the baseline bags in no particular order. Each pair was tested on both machines. The first two available pairs of UHR values were used for data analysis. The 3rd pair was used only if one of the first two samples did not produce a valid test result. DOB values were generated by the two instruments for each Baseline and Post Dose pair. UHR values were claculated based on the DOB values and the subject's anthropometric variables (age, gender, ehight and body weight).
Time frame: Baseline, Post Dose (15 min)
Population: Evaluable patients must drink all of the Pranactin-citric solution. Though all three sets of bags were analysed, the first two sets of valid values were used for analysis, regardless of the set designation (A, B or C). The values of individual sets (A, B or C) were not analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Urea Hydrolysis Rate (UHR) Values | Agreement Between POCone and UBiT-IR300. | Deming Regression Analysis | 0.990 |
| Urea Hydrolysis Rate (UHR) Values | Agreement Between POCone and UBiT-IR300. | Passing-Bablok Regression Analysis | 0.995 |
| Urea Hydrolysis Rate (UHR) Values | Agreement Between POCone and UBiT-IR300. | Regular Regression Analysis | 0.990 |
95% CI: [0.987, 0.993]Deming Regression
95% CI: [-0.25, 0.17]Deming Regression
95% CI: [0.987, 0.993]Regression, Linear
95% CI: [-0.24, 0.18]Regression, Linear
95% CI: [0.99, 1]Passing-Bablock
Comparison: While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.95% CI: [-0.3, 0.01]Passing-Bablok
Comparison: Comparison of UHR Values obtained by UBit-IR300 and POCone were used to identify participants' H.pylori infection status. Participants with UHR value ≥ 10.0μg/min were considered positive for H.Pylori.95% CI: [85.8, 100]
95% CI: [94.9, 100]
Other Pre-specified
Number of Participants Tested Positive/Negative for H. Pylori
Qualified subjects from clinical sites underwent a standard urea breath test using the BreathTek UBT Kit. Breath samples were analyzed using both the POCone and the UBiT-IR300. DOB values from these two infrared spectrophotometers were converted to respective UHR values using pUHR-CA. The paired UHR values from each subject were evaluated for agreement. UHR values of \>10 µg/min were considered positive for H. pylori and UHR values of \<10 µg/min were considered negative for H. pylori.
Time frame: Single Study Visit (1 hour of testing)
Population: 95 evaluable subjects for initial diagnosis - each patient received the BreathTek UBT test. Collected breath samples were analyzed on both the UBiT-IR300 and the POC-one.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Urea Hydrolysis Rate (UHR) Values | Number of Participants Tested Positive/Negative for H. Pylori | Positive for H.pylori | 24 Participants |
| Urea Hydrolysis Rate (UHR) Values | Number of Participants Tested Positive/Negative for H. Pylori | Negative for H. pylori | 71 Participants |
| POCone | Number of Participants Tested Positive/Negative for H. Pylori | Positive for H.pylori | 24 Participants |
| POCone | Number of Participants Tested Positive/Negative for H. Pylori | Negative for H. pylori | 71 Participants |