Back to resultsPOCone-UBiT-IR300 Pediatric Comparison Study
Primary Purpose
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pranactin citric solution
Sponsored by
About this trial
This is an interventional diagnostic trial for Bacterial Infection Due to Helicobacter Pylori (H. Pylori) focused on measuring Helicobacter pylori
Eligibility Criteria
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
Sites / Locations
- Miami Pediatric Gastroenterology
- University of Texas School of Public Health
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
BreathTek UBT
Arm Description
Comparison of Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT-IR300
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01623154
First Posted
June 15, 2012
Last Updated
February 2, 2015
Sponsor
Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT01623154
Brief Title
POCone-UBiT-IR300 Pediatric Comparison Study
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka America Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Keywords
Helicobacter pylori
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BreathTek UBT
Arm Type
Other
Arm Description
Comparison of Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT-IR300
Intervention Type
Other
Intervention Name(s)
Pranactin citric solution
Intervention Description
All patients were required to drink the pranactic citric solution to diagnose H.pylori.
Primary Outcome Measure Information:
Title
Agreement Between POCone and UBiT-IR300.
Description
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)
Other Pre-specified Outcome Measures:
Title
Number of Participants Tested Positive/Negative for H. Pylori
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Miami Pediatric Gastroenterology
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
University of Texas School of Public Health
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
12. IPD Sharing Statement
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POCone-UBiT-IR300 Pediatric Comparison Study
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