Breath Ammonia Method for H. Pylori Detection: Phase II

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

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

PHASE2

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2005-06-30

Brief Summary

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

The objective is to evaluate the utility of a breath ammonia sensing device. In this study we will assess the effect of H. pylori infection on breath ammonia levels by measuring whether there is a change in the pattern or quantity of breath ammonia seen in H. pylori positive patients compared to H. pylori negative patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori

NCT02010112

Helicobacter Pylori Infection

COMPLETED PHASE3

Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community-AIM 2

NCT07224048

H. Pylori Infection Gastric Cancer Gastritis H Pylori

RECRUITING PHASE4

Effect of Oral Helicobacter Pylori Infection on the Efficacy of Gastroluminal Helicobacter Pylori Eradication Therapy

NCT05790525

Helicobacter Pylori

COMPLETED PHASE4

Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases

NCT00366509

Pulmonary Disease Oropharyngeal Disease Lymphangioleiomyomatosis +3 more

COMPLETED

H. Pylori Testing for Patients With Non-specific Upper Abdominal Pain in the Emergency Department

NCT01376414

Gastritis Peptic Ulcer Peptic Ulcer Perforation +1 more

COMPLETED

Detailed Description

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

Healthy volunteers will undergo testing for H. pylori infection using a 14-C urea breath test, and the results will be compared to an experimental ammonia breath test. The breath sample will be collected by an investigational device that the patient will be exposed to consisting of a plastic mouth-piece which is attached to a T-tubing section having a side-arm port through which a fiberoptic ammonia sensor is inserted inside the tube. To meet the Phase II specific aim, the scope of the clinical trials is expanded addressing the following specific objectives:

* Test refinements of the sensing system (hardware, software, \& breath test device)
* Determine whether a urea dose-response effect exists following urea ingestion,
* Define the optimal cutoff values for expired breath ammonia to allow optimal discrimination of H. pylori infected vs. uninfected persons.
* Determine the appropriate time interval for breath ammonia testing following urea ingestion.
* Determine whether there is a change in breath ammonia level after H. pylori treatment.

Conditions

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

Helicobacter Infections

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Interventions

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

H. pylori treatment

Intervention Type DRUG

Eligibility Criteria

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

Exclusion Criteria

* Known cirrhosis of the liver
* Renal insufficiency (BUN greater than 40 mg/dl, Creatinine greater than 2.0 mg/dl).
* Prior gastric resection
* Severe chronic obstructive pulmonary disease (Forced expiratory volume in 1 second less than 1.5 L)
* Patients unwilling or unable to discontinue proton pump inhibitors for 2 weeks prior to scheduled 14C or non-isotopic urea breath testing
* Patients who have received antibiotics or bismuth within the preceding month.
* Patients unwilling or unable to give informed consent
* Pregnant women (14C urea breath test is not approved for use in pregnant women)
* Age less than 21 years (14C urea breath test is not approved for use in children)

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes