Helicobacter Pylori Infection
Conditions
Brief summary
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
Detailed description
Pediatric subjects with indication for H.pylori testing, will be tested with both stool antigen as a reference standard and a urea breath test using the BreathID® Hp and BreathID® Hp Lab Systems. The BreathID® Hp system continuously measures breath via a nasal cannula and the BreathID® Hp Lab System measures breath collection bags before and after ingestion of a solution with enriched carbon 13 urea and citric acid. The stool sample will be provided within a week of the breath tests and will be analyzed by a central laboratory. Safety and overall efficacy will be assessed.
Interventions
DEVICEBreathID® Hp System
Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea
DRUGBreathID® Hp Lab System
Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea
DIAGNOSTIC_TESTStool Test
Each subject was asked to perform a stool test in parallel to the breath test.
Sponsors
Meridian Bioscience, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The investigator and treating physician will remain blinded to the breath test results until the end of the study. There is only one arm.
Intervention model description
A 13C labeled substrate is used as part of a combination product; a diagnostic breath test.
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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.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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reported Adverse Events | 24 hours | Number of participants with reported adverse events after performing urea breath test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Israel, United States
Participant flow
Pre-assignment details
One subject (or parent) signed the consent, but before washout period was completed, decided to withdraw from trial. Therefore, from the 54 consented, only 53 started the study procedure.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Device Malfunction | 1 |
| Overall Study | Protocol Violation | 11 |
Baseline characteristics
| Characteristic | Indication for Helicobacter Pylori Testing |
|---|---|
| Age, Categorical <=18 years | 53 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Region of Enrollment Israel | 16 participants |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 1 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
Primary
Number of Participants With Reported Adverse Events
Number of participants with reported adverse events after performing urea breath test
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Indication for Helicobacter Pylori Testing | Number of Participants With Reported Adverse Events | 1 Participants |
Secondary
Percentage of Agreement
Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection
Time frame: 1 week
Population: Although 42 subjects completed the protocol, there was a device malfunction in this arm, therefore only 41 performed the continuous test.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Indication for Helicobacter Pylori Testing | Percentage of Agreement | 97.56 percentage of pos. or neg. agreeement |
Secondary
Percentage of Agreement
Percentage of agreement between stool test reference standard and breath bags from urea breath test in assessing presence or absence of Helicobacter pylori infection
Time frame: 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Indication for Helicobacter Pylori Testing | Percentage of Agreement | 97.62 percentage of pos. or neg. agreeement |