Trial · NCT02905825
Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics
NCT02905825, Phase 3, Completed, Meridian Bioscience, Inc.; results first posted 2018-07-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics. Trials, record NCT02905825. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02905825
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics
- NCT number
- NCT02905825
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 54 participants, actual
- Lead sponsor
- Meridian Bioscience, Inc.
- Conditions
- Helicobacter Pylori Infection
- Interventions
- BreathID® Hp System, BreathID® Hp Lab System, Stool Test
- First posted
- 2016-09-19
- Last updated
- 2022-12-20
- Results first posted
- 2018-07-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Reported Adverse Events | 24 hours | Number of participants with reported adverse events after performing urea breath test |
| Secondary | Percentage of Agreement | 1 week | Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection |
| Secondary | Percentage of Agreement | 1 week | Percentage of agreement between stool test reference standard and breath bags from urea breath test in assessing presence or absence of Helicobacter pylori infection |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Reported Adverse Events | 24 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Agreement | 1 week | Although 42 subjects completed the protocol, there was a device malfunction in this arm, therefore only 41 performed the continuous test. | percentage of pos. or neg. agreeement | NUMBER |
| SECONDARY | Percentage of Agreement | 1 week | percentage of pos. or neg. agreeement | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Reported Adverse Events | Indication for Helicobacter Pylori Testing | 1 | Participants | ||
| Percentage of Agreement | Indication for Helicobacter Pylori Testing | 97.56 | 95% Confidence Interval 87.14 to 99.94 | percentage of pos. or neg. agreeement | |
| Percentage of Agreement | Indication for Helicobacter Pylori Testing | 97.62 | 95% Confidence Interval 87.43 to 99.94 | percentage of pos. or neg. agreeement |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Indication for Helicobacter Pylori Testing | 53 | |
| Overall Study | COMPLETED | Indication for Helicobacter Pylori Testing | 41 | |
| Overall Study | NOT COMPLETED | Indication for Helicobacter Pylori Testing | 12 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | Indication for Helicobacter Pylori Testing | 1 | 53 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Indication for Helicobacter Pylori Testing | 0 | 53 |
| Total, other adverse events | Indication for Helicobacter Pylori Testing | 1 | 53 |
| Total, serious adverse events | Indication for Helicobacter Pylori Testing | 0 | 53 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02905825
GET https://conductscience.org/api/trials/v1/NCT02905825/registered