Clinical trial NCT01623154: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Keywords: Helicobacter pylori
Lead sponsor: Otsuka America Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-06-19
Enrollment: 99
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Agreement Between POCone and UBiT-IR300.
timeFrame: Baseline, Post Dose (15 min)
Secondary outcomes:
Other outcomes:
measure: Number of Participants Tested Positive/Negative for H. Pylori
timeFrame: Single Study Visit (1 hour of testing)
Locations:
city: Miami
country: United States
facility: Miami Pediatric Gastroenterology
state: Florida
city: El Paso
country: United States
facility: University of Texas School of Public Health
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: