POCone-UBiT-IR300 Pediatric Comparison Study

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

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
• Intervention / Treatment: Other: Pranactin citric solution

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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33155
      • Miami Pediatric Gastroenterology
  • Texas
    • El Paso, Texas, United States, 79902
      • University of Texas School of Public Health
    • Houston, Texas, United States, 77054
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: BreathTek UBT; 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.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Single Study Visit (1 hour of testing)

Collaborators and Investigators

• Sponsor: Otsuka America Pharmaceutical

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: June 15, 2012
• First Submitted That Met QC Criteria: June 18, 2012
• First Posted (ESTIMATE): June 19, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 23, 2015
• Last Update Submitted That Met QC Criteria: February 2, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Helicobacter pylori
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: UBT-1l-202