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

Not Applicable

Completed

• Conditions: Healthy Volunteers; Chronic Liver Disease (CLD)
• Interventions: Device: MPBA System; Device: BreathID

• Registration Number: NCT02187601
• Lead Sponsor: Meridian Bioscience, Inc.

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.

Study Timeline

• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-09
• Study First Posted: 2014-07-11
• Study Start: 2014-08
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HV with MPBA and BID	BreathID	Healthy volunteers (HV) with no known liver disease will undergo the breath test with the MPBA and the BID before and after substrate ingestion.
CLD with MPBA and BID	MPBA System	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.
CLD with MPBA and BID	BreathID	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.
HV with MPBA and BID	MPBA System	Healthy volunteers (HV) with no known liver disease will undergo the breath test with the MPBA and the BID before and after substrate ingestion.

Primary Outcome Measures

Name	Time	Method
DOB Peak	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.

Secondary Outcome Measures

Name	Time	Method
Number of subjects with adverse events related to breath test substrate	48 hours	Adverse events within 48 hours of the breath test will be recorded

Trial Locations

Locations (1)

Assaf Harofe Medical Center; 🇮🇱 Tzrifin, Israel