POCone-UBiT-IR300 Pediatric Comparison Study
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|ClinicalTrials.gov Identifier: NCT01623154|
Recruitment Status : Completed
First Posted : June 19, 2012
Results First Posted : January 13, 2015
Last Update Posted : February 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Infection Due to Helicobacter Pylori (H. Pylori)||Other: Pranactin citric solution||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||July 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||April 2013|
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
All patients were required to drink the pranactic citric solution to diagnose H.pylori.
- Agreement Between POCone and UBiT-IR300. [ Time Frame: 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).
- Number of Participants Tested Positive/Negative for H. Pylori [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623154
|United States, Florida|
|Miami Pediatric Gastroenterology|
|Miami, Florida, United States, 33155|
|United States, Texas|
|University of Texas School of Public Health|
|El Paso, Texas, United States, 79902|
|Baylor College of Medicine|
|Houston, Texas, United States, 77054|