Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics

Completed · Phase 3

Conditions studied: Helicobacter Pylori Infection

In brief

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

Key facts

Study ID

NCT02905825

Run by

Meridian Bioscience, Inc.

People needed

54

Starts

2017-05-18

Expected to finish

2017-11-05

Last updated by the study team

2022-12-20

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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