Phase 3
N=53
Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics
Helicobacter Pylori Infection
Bottom Line
View on ClinicalTrials.gov: NCT02905825 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Number of Participants With Reported Adverse Events — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BreathID® Hp System (Device); BreathID® Hp Lab System (Drug); Stool Test (Diagnostic_test)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Meridian Bioscience, Inc.
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Reported Adverse Events |
1 | — |
| SECONDARY Percentage of Agreement |
97.62 | — |
| SECONDARY Percentage of Agreement |
97.62 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT02905825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.