POCone-UBiT-IR300 Pediatric Comparison Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Multi-Center, Open-Label Study to Compare the POCone® With the UBiT®-IR300 in Measurement of 13CO2/12CO2 Ratio in Breath Samples Collected From Pediatric Subjects Ages 3 to 17 Years With Upper Gastrointestinal Signs and Symptoms

Conditions
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Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Intervention / Treatment
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* Other: Pranactin citric solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subject ages 3 to 1711/12 years. Subject with upper gastrointestinal signs and symptoms (e.g., abdominal pain/discomfort, bloating, nausea, or vomiting, etc.) Subject and/or parent/legal guardian is capable of giving assent or consent. Subject is able to complete the urea breath test by investigator's assessment. Exclusion Criteria: Subject is hypersensitive to mannitol, citric acid and/or aspartame. Previous diagnosis of phenylketonuria (PKU. Subject with difficulty swallowing or who may be at high risk for aspiration due to medical or physical conditions. Subjects with ongoing respiratory conditions or on bronchodilators that may compromise the collection of breath samples. Subjects with severe chronic illness (e.g., Crohn's disease, leukemia, kidney diseases, etc.) Administration of bismuth preparations (e.g., Pepto-Bismol®) at anytime within 14 days prior to the testing. Administration of antibiotics (e.g., amoxicillin, tetracycline, metronidazole, clarithromycin, azithromycin, etc.) therapy at anytime within 14 days prior to the testing. Administration of proton pump inhibitors (PPI; e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, pantoprazole, etc.) at anytime within 14 days prior to the testing. Administration of Histamine H2 receptor antagonist (H2RA; e.g., ranitidine, cimetidine, famotidine, nizatidine, etc.) at anytime within 24 hours prior to the testing. Treatment for eradication of H pylori within 28 days before testing or retesting. Participation in a drug or device study within 30 days of testing

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BreathTek UBT<br>Comparison of Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT-IR300 | Other: Pranactin citric solution<br>* All patients were required to drink the pranactic citric solution to diagnose H.pylori.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, Post Dose (15 min) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori