POCone-UBiT-IR300 Pediatric Comparison Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-04-30

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.

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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.

Conditions

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Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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BreathTek UBT

Comparison of Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT-IR300

Group Type OTHER

Pranactin citric solution

Intervention Type OTHER

All patients were required to drink the pranactic citric solution to diagnose H.pylori.

Interventions

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Pranactin citric solution

All patients were required to drink the pranactic citric solution to diagnose H.pylori.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No