Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02905825 | Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics | PHASE3 | COMPLETED | 54 | — | — | May 18, 2017 | Nov 5, 2017 | Dec 20, 2022 | 6 | United States, Israel |
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...