Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics
NCT ID: NCT02905825
Last Updated: 2022-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
54 participants
INTERVENTIONAL
2017-05-18
2017-11-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Indication for Helicobacter pylori testing
Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other.
BreathID® Hp System
Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea
BreathID® Hp Lab System
Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea
Stool Test
Each subject was asked to perform a stool test in parallel to the breath test.
Interventions
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BreathID® Hp System
Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea
BreathID® Hp Lab System
Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea
Stool Test
Each subject was asked to perform a stool test in parallel to the breath test.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Years
18 Years
ALL
No
Sponsors
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Meridian Bioscience, Inc.
INDUSTRY
Responsible Party
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Locations
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Willis-Knighton Pediatric GI Specialist/Willis-Knighton Physician Network
Shreveport, Louisiana, United States
Gastrointestinal Associates
Flowood, Mississippi, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Children's Health - Children's Medical Center Dallas (UT Southwestern)
Dallas, Texas, United States
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States
Assaf Harofe Medical Center
Tzrifin, , Israel
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PED-HP-0616B
Identifier Type: -
Identifier Source: org_study_id