- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02010112
Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori
December 19, 2022 updated by: Meridian Bioscience, Inc.
Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the Dual Mode BreathID® Hp System Compared to Congruent Biopsy Results
A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz.
In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will validate a breath collection method by comparing a newly developed breath test kit, IDkit:Hp™ TWO using breath collection bags, to congruent biopsy results (a composite reference standard by analyzing specimens with microbial culture, histological examination and rapid urease test- RUT) in detecting H.Pylori
Study Type
Interventional
Enrollment (Actual)
193
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21229
- Digestive Disease Associates, PA
-
Chevy Chase, Maryland, United States, 20815
- Metropolitan Gastroenterology Group
-
-
Michigan
-
Detroit, Michigan, United States, 48377
- Henry Ford Health System
-
-
Mississippi
-
Ocean Springs, Mississippi, United States, 39564
- Digestive Health Care
-
-
New York
-
Bronx, New York, United States, 10467
- Montefiore Hospital
-
-
Rhode Island
-
Warwick, Rhode Island, United States, 02886
- Omega Medical Research
-
-
Tennessee
-
Jackson, Tennessee, United States, 38305
- Clinical Research Solutions
-
-
Texas
-
Houston, Texas, United States, 77011
- JM Research
-
-
Virginia
-
Richmond, Virginia, United States, 23226
- Bon Secours Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Present with clinical indication of H. pylori and candidate for upper endoscopy
- Have the ability and willingness to sign the Informed Consent Form for initial diagnosis cohort
- Naive to treatment in the past 18 months
- No known H.pylori status (no conclusive test results within last 6 months)
Exclusion Criteria:
- Participation in other interventional trials
- Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test
- PPI (proton pump inhibitors) or H2 blockers within two (2) weeks prior to breath test
- Pregnant or breastfeeding women
- Allergy to test substrates
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Initial Diagnosis Cohort
Subjects with clinical indication of H.pylori infection will undergo breath test compared to routine clinical standard of care- endoscopy
|
Breath Collection bags will be used to collect breath of subjects before and after ingestion of 13-C breath test substrate
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall percent agreement
Time Frame: 21 days
|
The primary study endpoint is the performance measure (overall percent agreement) in initial diagnosis (presence/ absence of H.pylori) between biopsy results and bag mode breath test.
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall percent agreement
Time Frame: 21 days
|
The performance measure (overall percent agreement) in post-therapy diagnosis (presence/ absence of H.pylori) between the Dual Mode BreathID® Hp System when using only one pair of IDkit:Hp™ TWO breath collection bags measured within 9 days and congruent biopsy results
|
21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Melina Arazy, M.D., VP of clinical affairs, Exalenz
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
December 5, 2013
First Submitted That Met QC Criteria
December 9, 2013
First Posted (Estimate)
December 12, 2013
Study Record Updates
Last Update Posted (Actual)
December 20, 2022
Last Update Submitted That Met QC Criteria
December 19, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DM-MPBA-0813
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Helicobacter Pylori Infection
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...RecruitingHelicobacter Pylori Infection | Helicobacter Pylori EradicationBangladesh
-
Shandong UniversityRecruitingHelicobacter Pylori Infection | Patient Education | Helicobacter Pylori EradicationChina
-
Shandong UniversityCompletedHelicobacter Pylori Infection Helicobacter Pylori Eradication Patient EducationChina
-
Shanghai Jiao Tong University School of MedicineCompletedCure Rate of Helicobacter Pylori InfectionChina
-
Seoul National University Bundang HospitalRecruitingHelicobacter Pylori Infection | Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation | Helicobacter Pylori Associated Gastrointestinal Disease | Helicobacter Pylori Infection, Susceptibility toKorea, Republic of
-
The First Affiliated Hospital of Nanchang UniversityUnknownBacterial Infection Due to Helicobacter Pylori (H. Pylori) | Eradication Therapy of Helicobacter Pylori | Detection of Helicobacter PyloriChina
-
Tanta UniversityNot yet recruitingPersistent Helicobacter Pylori InfectionEgypt
-
Nanjing First Hospital, Nanjing Medical UniversityCompletedHelicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)Helicobacter Pylori Infection | Helicobacter Pylori gyrA Levofloxacin Resistance Mutation | Fecal Drug Resistance Gene Detection | Helicobacter Pylori Infection, Susceptibility toChina
-
National University Hospital, SingaporeUnknownHELICOBACTER PYLORI INFECTIONSSingapore
-
Kaohsiung Veterans General Hospital.Kaohsiung Medical University Chung-Ho Memorial HospitalCompletedHelicobacter Pylori InfectionTaiwan
Clinical Trials on Breath Test Collection bags
-
Yonsei UniversityUnknownIrritable Bowel SyndromeKorea, Republic of
-
Indiana UniversityEnrolling by invitationHealthy | Respiratory DiseaseUnited States
-
Brain-Gut Research GroupNational University, Singapore; New Jersey Medical SchoolCompletedIrritable Bowel Syndrome | Functional Gastrointestinal DisordersSwitzerland
-
Assistance Publique - Hôpitaux de ParisRecruitingCystic FibrosisFrance
-
National University Hospital, SingaporeNational Taiwan University Hospital; Chinese University of Hong Kong; Singapore... and other collaboratorsActive, not recruitingStomach NeoplasmTaiwan, United States, Singapore, Hong Kong, Japan, Korea, Republic of
-
Landon Pediatric FoundationCompleted
-
Mebo Research, Inc.Aurametrix; Menssana Research, Inc.CompletedNutritional and Metabolic DiseasesUnited States, United Kingdom
-
Imperial College LondonThe Leeds Teaching Hospitals NHS Trust; Sheffield Teaching Hospitals NHS Foundation... and other collaboratorsRecruitingPancreatic Cancer | PDAC - Pancreatic Ductal AdenocarcinomaUnited Kingdom
-
Menssana Research, Inc.National Heart, Lung, and Blood Institute (NHLBI)Completed
-
Emory UniversityMichael J. Fox Foundation for Parkinson's ResearchCompletedDefining a PD-specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative ProcessesParkinson's DiseaseUnited States