Chronic Liver Disease (CLD)NCT02187601
Equivalence of New Breath AnalyzerCompared to Currently BreathID System in Assessment of Liver Function
A study testing MPBA System and BreathID in people with Chronic Liver Disease (CLD) and Healthy Volunteers, run by Meridian Bioscience, Inc. at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Liver Disease (CLD), Healthy Volunteers
- What is being tested?
- MPBA System and BreathID
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Liver Disease (CLD), Healthy Volunteers
- Being tested
- MPBA System, BreathID
- Keywords
- CLD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPBA SystemDevice
Also called Multi Purpose Breath Analyzer, BreathID LF
MPBA is the new generation Multi Purpose Breath Analyzer
BreathIDDevice
BreathID is the name of the original Exalenz breath analyzer system
| Study group | Role | What they receive |
|---|---|---|
| CLD with MPBA and BID | Experimental | 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. Receives: Device: MPBA System; Device: BreathID |
| HV with MPBA and BID | Experimental | Healthy volunteers (HV) with no known liver disease will undergo the breath test with the MPBA and the BID before and after substrate ingestion. Receives: Device: MPBA System; Device: BreathID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One hour
Secondary outcomes (1)
Number of subjects with adverse events related to breath test substrate
Adverse events within 48 hours of the breath test will be recorded
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver Disease (CLD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saleh Daher, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187601
- Sponsor's protocol ID
- LF-BETA-EX-0614
- Status last verified
- Dec 2022
- First submitted
- 7 Jul 2014
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02187601
- Acronym / sponsor ID
- LF-BETA-EX-0614
- Conditions
- Chronic Liver Disease (CLD), Healthy Volunteers
- Keywords
- CLD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLD with MPBA and BID | Experimental | Device: MPBA System, Device: BreathIDChronic 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 | Experimental | Device: MPBA System, Device: BreathIDHealthy volunteers (HV) with no known liver disease will undergo the breath test with the MPBA and the BID before and after substrate ingestion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 years of age
- Ability and willingness to sign the Informed Consent Form
- a. Known chronic liver disease (based on medical history)
- 3.b. No known liver disease (based on medical history)
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPBA SystemAlso: Multi Purpose Breath Analyzer, BreathID LFMPBA is the new generation Multi Purpose Breath Analyzer | Device | CLD with MPBA and BID, HV with MPBA and BID |
| BreathIDBreathID is the name of the original Exalenz breath analyzer system | Device | CLD with MPBA and BID, HV with MPBA and BID |
Primary outcome
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.
1 secondary outcome
Number of subjects with adverse events related to breath test substrate
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Chronic Liver Disease (CLD)
RecruitingPhase 4
Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza / Zemaira Weekly for 3 Years in Adults With alpha1 Antitrypsin Deficiency (AATD)
Alpha1 Antitrypsin Deficiency, Alpha1-Proteinase Inhibitor Deficiency
Recruiting
EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG
Portal Hypertension, Chronic Liver Disease (CLD)
RecruitingObservational study
To Study the Clinical Course and Outcomes of Non-electively Hospitalised Patients of Chronic Liver Disease (CLD) With Hepatic or Extra-hepatic Predominant Organ Failure(s) at 6 Months.
Chronic Liver Disease
RecruitingPhase 4
Vitamin D2 vs Vitamin D2 Plus Calcitriol in Cholestatic Children With Vitamin D Deficiency
Cholestatic Liver Disease, Chronic Liver Disease (CLD)
Active, not recruitingObservational study
Identification of Patients With Advanced Chronic Diseases in Need of Palliative Care
Cancer, Chronic Liver Disease (CLD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saleh Daher, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPBA System and BreathID in people with Chronic Liver Disease (CLD) and Healthy Volunteers, run by Meridian Bioscience, Inc. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DOB Peak (time frame: One hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.