Equivalence of New Breath AnalyzerCompared to Currently BreathID System in Assessment of Liver Function

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02187601
• Other study ID #: LF-BETA-EX-0614
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: March 2017

Study information

• Verified date: December 2022
• Source: Meridian Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Over 18 years of age

2. Ability and willingness to sign the Informed Consent Form

For patient group:

3. a. Known chronic liver disease (based on medical history)

For healthy volunteers:

3.b. No known liver disease (based on medical history)

Exclusion Criteria:

1. Gastric bypass surgery or extensive small bowel resection

2. Total parenteral nutrition

3. Pregnant or breast feeding

4. Allergy to acetaminophen and/or other related medications.

5. Documented drug-related concurrent hepatotoxicity or drug-related silent steatosis or drug-related fibrosis (e.g. amiodarone, methotrexate and tamoxifen).

6. Uncontrolled malabsorption or diarrhea

7. Placement of a transjugular intrahepatic portosystemic shunt (TIPS)

8. 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

9. Subject should not have taken amiodarone within the last 30 days prior to the breath test

Related Conditions & MeSH terms

• Chronic Liver Disease (CLD)
• Healthy Volunteers
• Liver Diseases

Intervention

Device:
• MPBA System
MPBA is the new generation Multi Purpose Breath Analyzer
• BreathID
BreathID is the name of the original Exalenz breath analyzer system

Locations

Country	Name	City	State
Israel	Assaf Harofe Medical Center	Tzrifin

Sponsors (1)

Lead Sponsor	Collaborator
Meridian Bioscience, Inc.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DOB Peak	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.	One hour
Secondary	Number of subjects with adverse events related to breath test substrate	Adverse events within 48 hours of the breath test will be recorded	48 hours