POCone-UBiT-IR300 Pediatric Comparison Study

Bacterial Infection Due to Helicobacter Pylori (H. Pylori) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623154
• Other study ID #: UBT-1l-202
• Status: Completed
• Phase: Phase 4
• First received: June 15, 2012
• Last updated: February 2, 2015
• Start date: July 2012
• Est. completion date: April 2013

Study information

• Verified date: January 2015
• Source: Otsuka America Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
• Bacterial Infections
• Signs and Symptoms, Digestive

Intervention

Other:
• Pranactin citric solution
All patients were required to drink the pranactic citric solution to diagnose H.pylori.

Locations

Country	Name	City	State
United States	University of Texas School of Public Health	El Paso	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	Miami Pediatric Gastroenterology	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka America Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	No
Primary	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)	Yes