Beta Study to Evaluate Functionality and Equivalence of MPBA (Multi Purpose Breath Analyzer-new Generation Exalenz Breath Analyzer) Compared to Currently Approved BreathID System in Assessment of Liver Function

Meridian Bioscience, Inc.1 site in 1 country20 target enrollmentAugust 2014

ConditionsChronic Liver Disease (CLD)Healthy Volunteers

Overview

Phase: N/A
Intervention: Not specified
Conditions: Chronic Liver Disease (CLD)
Sponsor: Meridian Bioscience, Inc.
Enrollment: 20
Locations: 1
Primary Endpoint: DOB Peak
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the study is to confirm that the new generation state of the art breath analyzer gives equivalent results to the previous model of the Exalenz breath analyzer.

Detailed Description

Healthy and chronic liver disease subjects of all grades will be tested to see that the two devices give equivalent results in both devices. Subjects will be connected to both devices at the same time and will be tested for one hour. The breath test includes automatic baseline breath collection, 13C-Methacetin ingestion in solution and breath collection post ingestion.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

March 2017

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Meridian Bioscience, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Over 18 years of age
•Ability and willingness to sign the Informed Consent Form
•For patient group:
•a. Known chronic liver disease (based on medical history)
•For healthy volunteers:
•3.b. No known liver disease (based on medical history)

Exclusion Criteria

•Gastric bypass surgery or extensive small bowel resection
•Total parenteral nutrition
•Pregnant or breast feeding
•Allergy to acetaminophen and/or other related medications.
•Documented drug-related concurrent hepatotoxicity or drug-related silent steatosis or drug-related fibrosis (e.g. amiodarone, methotrexate and tamoxifen).
•Uncontrolled malabsorption or diarrhea
•Placement of a transjugular intrahepatic portosystemic shunt (TIPS)
•Subject should not have taken any of the following for at least 48 hours prior to the breath test: Acyclovir, allopurinol, carbamazepine, cimetidine, ciprofloxacin, daidzein, (herbal) disulfiram, echinacea, enoxacin, famotidine, fluvoxamine, methoxsalen, mexiletine, montelukast, norfloxacin, phenylpropanolamine, phenytoin, propafenone, rifampin, terbinafine, ticlopidine, thiabendazole, verapamil, zileuton or oral contraceptives or any medication that might interfere with Methacetin metabolism or might affect CYP 1A2
•Subject should not have taken amiodarone within the last 30 days prior to the breath test

Outcomes

Primary Outcomes

DOB Peak

Time Frame: One hour

The DOB (Delta over Baseline) is measured before and after ingestion of challenging test substrate: 13C- Methacetin. The peak of the DOB is indicative of liver health.