MedDataX Logo

Show Equivalence of the Modified BreathID Compared to Currently Approved BreathID in H.Pylori Detection

NCT ID: NCT01650831

Last Updated: 2022-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to confirm equivalence of a new generation breath analyzer (Modified BreathID) in its ability to detect H. pylori compared to the currently approved BreathID® System.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The ¹³C-Urea Breath Test (UBT) is a non-invasive test for detecting the presence of Helicobacter pylori (H. pylori) infection by the organism's urease activity. In the presence of H. pylori, the ingestion of urea, labeled with the non-radioactive isotope 13C, results in production of labeled 13CO2, which can be quantified in expired breath. Each test is performed using a test kit consisting of a 13C-urea tablet and citrica powder to be dissolved in tap water ("13C-urea solution"). Before and after ingestion of the 13C-urea solution, samples of exhaled breath can be collected using a nasal cannula for real-time analysis and comparison to baseline concentrations. The patient's exhaled breath is analyzed and the ratio between 13CO2 and 12CO2 is computed. The patient is considered H. pylori positive when the difference between the ratios exceeds a predefined threshold (5 delta over baseline (DOB)). The current device marketed by Exalenz is large and costly. Exalenz has built a smaller, cheaper and more reliable new generation device for this application. Equivalence is being demonstrated in this study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Suspicion of Being Infected With H.Pylori

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Helicobacter Pylori 13C Urea Breath Test BreathID

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clinical Suspicion of Hpylori

All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions

Group Type ACTIVE_COMPARATOR

Modified BreathID

Intervention Type DEVICE

A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Modified BreathID

A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BreathID Hp

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Be at least 18 years of age
2. Present with clinical indication of H. pylori
3. Have the ability and willingness to sign the Informed Consent Form-

Exclusion Criteria

1. Current serious disease
2. Participation in other trials
3. Antibiotics and/or Bismuth preparations for four (4) weeks prior to test
4. PPI or H2 blockers for two (2) weeks prior to test
5. Childbearing or breastfeeding women
6. Based on opinion of investigator, subject should not be enrolled in this trial
7. Allergy to citrus juice
8. Post -eradication therapy for H. pylori
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Meridian Bioscience, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jenny Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Unimed Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Unimed Center

East Brunswick, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Chey WD, Wong BC; Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol. 2007 Aug;102(8):1808-25. doi: 10.1111/j.1572-0241.2007.01393.x. Epub 2007 Jun 29.

Reference Type BACKGROUND
PMID: 17608775 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HP-MBI-0212

Identifier Type: -

Identifier Source: org_study_id