Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BreathID Hp Lab System · 1 trial · 1 indication
Number of participants with reported adverse events after performing urea breath test
| Arm | Type | Description |
|---|---|---|
| Indication for Helicobacter pylori testing | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| BreathID® Hp System | DEVICE | Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea |
| BreathID® Hp Lab System | DRUG | Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea |
| Stool Test | DIAGNOSTIC_TEST | Each subject was asked to perform a stool test in parallel to the breath test. |
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.pylor...
BreathID Hp Lab System is a diagnostic breath test used to detect Helicobacter pylori infection. It is a small molecule based system developed by Meridian Bioscience Inc. The test is intended for use in patients, including pediatric patients, to identify H. pylori, a bacterium associated with peptic ulcers and other gastrointestinal conditions.
BreathID Hp Lab System is used for the detection of Helicobacter pylori infection. It is a urea breath test that helps diagnose the presence of this bacterium in the stomach. The test is designed for use in both adults and pediatric patients, with clinical trials including children as young as 3 years old.
BreathID Hp Lab System is developed by Meridian Bioscience Inc, which trades under the ticker VIVO. Meridian Bioscience is a life science company that develops diagnostic tests and related products.
BreathID Hp Lab System has been studied in a Phase 3 clinical trial. The trial has been completed. As a diagnostic test, it is not a therapeutic drug, but it has undergone clinical development to evaluate its performance in detecting Helicobacter pylori infection.
BreathID Hp Lab System has been evaluated in one completed Phase 3 clinical trial, NCT02905825, titled "Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics." The trial enrolled 54 participants and was conducted in the United States and Israel, focusing on pediatric patients with Helicobacter pylori infection.
Yes, BreathID Hp Lab System is also known as BreathID® Hp Lab System. The registered trademark symbol is often included in the product name, but both refer to the same diagnostic breath test developed by Meridian Bioscience Inc.