Clinical trial NCT02905825: Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics
Official title: Clinical Confirmation Study to Confirm Safety and Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Lead sponsor: Meridian Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-19
Enrollment: 54
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A 13C labeled substrate is used as part of a combination product; a diagnostic breath test.
Primary purpose: DIAGNOSTIC

Brief summary: Clinical Study to Confirm Safety and Accuracy in Detection of H. pylori with 13C-Urea Breath Test using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population

Detailed description: Pediatric subjects with indication for H.pylori testing, will be tested with both stool antigen as a reference standard and a urea breath test using the BreathID® Hp and BreathID® Hp Lab Systems. The BreathID® Hp system continuously measures breath via a nasal cannula and the BreathID® Hp Lab System measures breath collection bags before and after ingestion of a solution with enriched carbon 13 urea and citric acid. The stool sample will be provided within a week of the breath tests and will be analyzed by a central laboratory. Safety and overall efficacy will be assessed.

Eligibility criteria: Inclusion Criteria:

* Be older than 3 and younger than 18 years of age
* Present with a clinical indication compatible with H. pylori based on the judgement of the treating physician (such as abdominal pain, nausea, diarrhea, reflux, peptic ulcer, dyspepsia, etc., or following treatment for H.pylori)
* Subject/Legal guardian (and subject whenever relevant) is willing to sign the Informed Consent/Assent Form
* Naïve to H. pylori treatment in the past 6 weeks

Exclusion Criteria:

* Participation in other interventional trials
* PPI or H2 blockers within two (2) weeks prior to breath test/stool antigen test
* Pregnant or breastfeeding female
* Allergy to test substrates
* Antibiotics (not related to H. pylori eradication) and/or Bismuth preparations within four (4) weeks prior to breath test
* Exposure to any type of anesthesia, analgesics or sedation 24 hours prior to the breath test.
* Exposure to any 13C-enriched substance 24 hours prior to the breath test.
* Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group
* Subjects outside US - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group

Primary outcomes:
measure: Number of Participants With Reported Adverse Events
timeFrame: 24 hours
Secondary outcomes:
measure: Percentage of Agreement
timeFrame: 1 week
measure: Percentage of Agreement
timeFrame: 1 week
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Willis-Knighton Pediatric GI Specialist/Willis-Knighton Physician Network
state: Louisiana
city: Flowood
country: United States
facility: Gastrointestinal Associates
state: Mississippi
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
city: Dallas
country: United States
facility: Children's Health - Children's Medical Center Dallas (UT Southwestern)
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine/Texas Children's Hospital
state: Texas
city: Tzrifin
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
References: