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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Liver Disease (CLD), Healthy Volunteers

Intervention / Treatment
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* Device: MPBA System
* Device: BreathID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLD with MPBA and BID<br>Chronic Liver Disease (CLD) patients of all degrees will be offered to be tested on the MPBA (multi purpose breath analyzer) and BID (BreathID) on a walk- in basis with , proving they meet inclusion/exclusion criteria. | Device: MPBA System<br>* MPBA is the new generation Multi Purpose Breath Analyzer<br>* Other names: BreathID LF;Device: BreathID<br>* BreathID is the name of the original Exalenz breath analyzer system<br>|
| Experimental: HV with MPBA and BID<br>Healthy volunteers (HV) with no known liver disease will undergo the breath test with the MPBA and the BID before and after substrate ingestion. | Device: MPBA System<br>* MPBA is the new generation Multi Purpose Breath Analyzer<br>* Other names: BreathID LF;Device: BreathID<br>* BreathID is the name of the original Exalenz breath analyzer system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLD