Healthy SubjectsPhase 2/3NCT01205074
¹³C-Methacetin Breath Test (MBT) Methodology Study
A Phase 2/3 study testing 13C Methacetin Breath Test, Grape fruit juice and Non selective beta blocker - Propranolol in people with Healthy Subjects and Chronic Liver Disease, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Several factors will be tested to see if they have an influence on the methacetin breath test results. Each one of the factors has been raised as a possible source of distortion of the MBT result. I. Variability between same tests on same subject MBT. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Chronic Liver Disease, Cirrhosis
- What is being tested?
- 13C Methacetin Breath Test, Grape fruit juice and Non selective beta blocker - Propranolol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to not given
- Phase
- Phase 2/3
- 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
- Adult subjects with 18 years of age or older
- Women of childbearing potential must have a negative serum or urinary hCG pregnancy test within 7 days prior to enrollment. During the study these women must use 2 methods of contraception.
- Subject has given written informed consent, prior to any study related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn at any time without prejudice to future medical care.
- Healthy Subjects:
- No known liver disease
- Non smokers
Show all 54Show fewer
- BMI =20-25 kg/m2
- Normal liver enzymes (ALT < 40 U/L for men, < 30 U/L for women)
- Not taking any medications
- No known on-going chronic medical conditions (apart from allergy or orthopaedic conditions not requiring chronic therapy).
- Normal abdominal ultrasound (US)
- Cirrhotics:
- Diagnosis of cirrhosis by liver biopsy
- Or strong suspicion of cirrhosis by accepted criteria for the clinical diagnosis of cirrhosis (e.g. peripheral edema or varices, palpable hard left lobe of the liver, small right lobe span or palpable splenomegaly), and/or radiological evidence of cirrhosis (by abdominal sonography, computer assisted axial tomography, or magnetic resonance imaging, showing a nodular liver and/or portosystemic collaterals with portal vein patency and/or ascites and/or splenomegaly, and/or colloid shift on a colloid-isotope liver-spleen scan), and/or laboratory variables (platelets <100,000/mm3, albumin< 3.5g/dL, or INR >1.3)
- Chronic Liver Patient (non cirrhotic):
- Patient who has been diagnosed with chronic liver disease for more than 6 months.
- No known liver disease
- BMI 20- 25 kg/m2
- Normal liver enzymes (ALT < 40 U/L for men, < 30 U/L for women)
- Patients with a COPD exacerbation with elevated PCO2 levels (> 50 mmHg)
- Without clinically overt right heart failure
- Ceased smoking for at least one month
- No other overt clinical dysfunction of major organ system
- Smokers:
- No known liver disease
- Active smoker of at least 10 cigarettes/day (stable number of cigarettes during past month - not currently trying to quit).
- BMI 20- 25 kg/m2
- Normal liver enzymes (ALT < 40 U/L for men, < 30 U/L for women)
- Not taking any medications
- No known chronic medical conditions
- Healthy Subjects:
- No known liver disease
- Non smokers
- BMI 20- 25 kg/m2
- Normal liver enzymes (ALT < 40 U/L for men, < 30 U/L for women)
- Not taking any medications
- No known chronic medical conditions (allergy or orthopaedic condition not requiring chronic therapy allowed).
- Normal abdominal US
- Cirrhotic subjects:
- Diagnosis of cirrhosis by liver biopsy
- Or strong suspicion of cirrhosis by accepted criteria for the clinical diagnosis of cirrhosis (e.g. peripheral edema or varices, palpable hard left lobe of the liver, small right lobe span or palpable splenomegaly), and/or radiological evidence of cirrhosis (by abdominal sonography, computer assisted axial tomography, or magnetic resonance imaging, showing a nodular liver and/or portosystemic collaterals with portal vein patency and/or ascites and/or splenomegaly, and/or colloid shift on a colloid-isotope liver-spleen scan), and/or laboratory variables (platelets <100,000/mm3, albumin< 3.5g/dL, or INR >1.3)
- Not receiving medication which is metabolized by CYP450 1A2
- Diagnosis of cirrhosis (by liver biopsy or clinical diagnosis):
- Strong suspicion of cirrhosis by accepted criteria for the clinical diagnosis of cirrhosis (e.g. peripheral edema or varices, palpable hard left lobe of the liver, small right lobe span or palpable splenomegaly), and/or radiological evidence of cirrhosis (by abdominal sonography, computer assisted axial tomography, or magnetic resonance imaging, showing a nodular liver and/or portosystemic collaterals with portal vein patency and/or ascites and/or splenomegaly, and/or colloid shift on a colloid-isotope liver-spleen scan), and/or laboratory variables (platelets <100,000/mm3, albumin< 3.5g/dL, or INR >1.3)
- Naive to Beta Blockers - with a clinical indication for initiating therapy (eg. esophageal varices, portal hypertensive gastropathy)
- Resting pulse > 60 beats per minute
- Non smoker
- No known liver disease
- Non smokers
- BMI 20- 25 kg/m2
- Normal liver enzymes (ALT < 40 U/L for men, < 30 U/L for women)
- Not taking any medications
- No known chronic medical conditions. (Allergy or orthopaedic condition not requiring chronic therapy allowed).
- Normal abdominal US
Who cannot join
- Severe heart, pulmonary or renal disease.
- Patient has previous surgical bypass surgery for morbid obesity
- Patient has extensive small bowel resection
- Any major surgery in the past 3 months.
- Patient is a recipient of any organ transplant
- Pregnant or breastfeeding women.
Show all 37Show fewer
- Patient allergic to acetaminophen
- Patients who are taking hepatotoxic drugs
- Patient, based on the opinion of the investigator, should not be enrolled into this study.
- Patients unable or unwilling to sign informed consent
- Patients that are participating in other clinical trials evaluating experimental treatments or procedures or have participated in a clinical trial in the past 3 months.
- Patient has not fasted for 8 hours.
- Patient has smoked on the day of the test.
- Patient that has taken drugs that can interfere with methacetin metabolism: fluvoxamine, amiodarone, ciprofloxacin, cimetidine, rifampin, carbamazepine within the last 24 hours.
- Patient has taken Tylenol or any other acetaminophen related medications within the past 24 hours.
- Patients that received any new medication in the last 48 hours.
- Patients that still suffer from any previous clinical intervention (e.g. biopsy)
- Have not consumed alcohol 24 hours prior the MBT and not consume on a regular basis more than 40gr for male and 20gr for female per day.
- General
- Severe heart, pulmonary or renal disease.
- Patient has previous surgical bypass surgery for morbid obesity
- Patient has extensive small bowel resection
- Any major surgery in the past 3 months.
- Patient is a recipient of any organ transplant
- Pregnant or breastfeeding women.
- Patient allergic to acetaminophen
- Patients who are taking hepatotoxic drugs
- Patient, based on the opinion of the investigator, should not be enrolled into this study.
- Patients unable or unwilling to sign informed consent
- Patients that are participating in other clinical trials evaluating experimental treatments or procedures or have participated in a clinical trial in the past 3 months.
- Patient has not fasted for 8 hours.
- Patient has smoked on the day of the test.
- Patient that has taken drugs that can interfere with methacetin metabolism: fluvoxamine, amiodarone, ciprofloxacin, cimetidine, rifampin, carbamazepine within the last 24 hours.
- Patient has taken Tylenol or any other acetaminophen related medications within the past 24 hours.
- Patients that received any new medication in the last 48 hours.
- Patients that still suffer from any previous clinical intervention (e.g. -
- Have not consumed alcohol 24 hours prior the MBT and not consume on a regular basis more than 40gr for male and 20gr for female per day.
Trial locations and contacts
1 site in 1 country.
About this study
Several factors will be tested to see if they have an influence on the methacetin breath test results. Each one of the factors has been raised as a possible source of distortion of the MBT result.
- Variability between same tests on same subject MBT. Repeatability will be tested in both healthy individuals and patients with chronic liver disease.
Read more
II. COPD - Chronic obstructive pulmonary disease is a leading cause of death worldwide, and can potentially have an effect on the MBT since the breath test is based on CO2 production and these subjects may have abnormal CO2 production.
III. Smoking- 13C Methacetin is metabolized by healthy hepatocytes reflecting hepatic microsomal function of CYP1A2, and smoking may cause induction of CYP1A2. Furthermore, internal preliminary data has shown signs that there is an influence of smoking on the MBT ranges.
IV. Age- Empirical data on several hundred subjects with chronic liver disease has shown that age is a significant factor in determining the probability of disease severity and preliminary data in normal subjects have shown changes in MBT with age.. Therefore, the effect of age has to be elucidated in an orderly fashion.
- CYP450 1A2 Inhibitors- Several drugs and food items inhibit CYP450 1A2 and may affect the MBT.
VI. Alcohol - Alcohol ingestion leads to induction of hepatic CYP and at a later stage to inhibition due to liver damage. Acute alcohol ingestion may therefore effect MBT results.
VII. Beta-blockers - beta blocker are affecting portal hypertension and may affect hepatic blood flow and thereby the outcome of the methacetin breath test.
- Conditions
- Healthy Subjects, Chronic Liver Disease, Cirrhosis
- Being tested
- 13C Methacetin Breath Test, Grape fruit juice, Non selective beta blocker - Propranolol, Ethanol
- Keywords
- Patients with chronic liver disease and cirrhosis
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C Methacetin Breath TestDevice
Grape fruit juiceDietary supplement
Non selective beta blocker - PropranololDrug
EthanolDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Repeatability | Experimental | Not described Receives: Device: 13C Methacetin Breath Test |
| COPD | Experimental | Not described Receives: Device: 13C Methacetin Breath Test |
| Smokers | Experimental | Not described Receives: Device: 13C Methacetin Breath Test |
| CYP450 1A2 Inhibitors | Experimental | Not described Receives: Device: 13C Methacetin Breath Test; Dietary Supplement: Grape fruit juice |
| Cirrhosis Beta Blockers | Experimental | Not described Receives: Device: 13C Methacetin Breath Test; Drug: Non selective beta blocker - Propranolol |
| Alcohol | Experimental | Not described Receives: Device: 13C Methacetin Breath Test; Dietary Supplement: Ethanol |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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 2/3
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Meridian Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205074
- Sponsor's protocol ID
- METH-EX-610- HMO - CTIL
- Status last verified
- Jun 2011
- First submitted
- 16 Sep 2010
- Last updated
- 28 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ¹³C-Methacetin Breath Test (MBT) Methodology Study
- ClinicalTrials.gov ID
- NCT01205074
- Acronym / sponsor ID
- METH-EX-610- HMO - CTIL
- Conditions
- Healthy Subjects, Chronic Liver Disease, Cirrhosis
- Keywords
- Patients with chronic liver disease and cirrhosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Meridian Bioscience, Inc.
- Study start
- Sep 2010
- First posted
- 20 Sep 2010 (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.
Several factors will be tested to see if they have an influence on the methacetin breath test results. Each one of the factors has been raised as a possible source of distortion of the MBT result.
- Variability between same tests on same subject MBT. Repeatability will be tested in both healthy individuals and patients with chronic liver disease.
II. COPD - Chronic obstructive pulmonary disease is a leading cause of death worldwide, and can potentially have an effect on the MBT since the breath test is based on CO2 production and these subjects may have abnormal CO2 production.
III. Smoking- 13C Methacetin is metabolized by healthy hepatocytes reflecting hepatic microsomal function of CYP1A2, and smoking may cause induction of CYP1A2. Furthermore, internal preliminary data has shown signs that there is an influence of smoking on the MBT ranges.
IV. Age- Empirical data on several hundred subjects with chronic liver disease has shown that age is a significant factor in determining the probability of disease severity and preliminary data in normal subjects have shown changes in MBT with age.. Therefore, the effect of age has to be elucidated in an orderly fashion.
- CYP450 1A2 Inhibitors- Several drugs and food items inhibit CYP450 1A2 and may affect the MBT.
VI. Alcohol - Alcohol ingestion leads to induction of hepatic CYP and at a later stage to inhibition due to liver damage. Acute alcohol ingestion may therefore effect MBT results.
VII. Beta-blockers - beta blocker are affecting portal hypertension and may affect hepatic blood flow and thereby the outcome of the methacetin breath test.
Study design
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Repeatability | Experimental | Device: 13C Methacetin Breath Test |
| COPD | Experimental | Device: 13C Methacetin Breath Test |
| Smokers | Experimental | Device: 13C Methacetin Breath Test |
| CYP450 1A2 Inhibitors | Experimental | Device: 13C Methacetin Breath Test, Dietary Supplement: Grape fruit juice |
| Cirrhosis Beta Blockers | Experimental | Device: 13C Methacetin Breath Test, Drug: Non selective beta blocker - Propranolol |
| Alcohol | Experimental | Device: 13C Methacetin Breath Test, Dietary Supplement: Ethanol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (54 listed)
- Adult subjects with 18 years of age or older
- Women of childbearing potential must have a negative serum or urinary hCG pregnancy test within 7 days prior to enrollment. During the study these women must use 2 methods of contraception.
- Subject has given written informed consent, prior to any study related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn at any time without prejudice to future medical care.
- No known liver disease
- Non smokers
Key exclusion criteria (37 listed)
- Severe heart, pulmonary or renal disease.
- Patient has previous surgical bypass surgery for morbid obesity
- Patient has extensive small bowel resection
- Any major surgery in the past 3 months.
- Patient is a recipient of any organ transplant
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 |
|---|---|---|
| 13C Methacetin Breath Test | Device | Alcohol, COPD, CYP450 1A2 Inhibitors, Cirrhosis Beta Blockers, Repeatability, Smokers |
| Grape fruit juice | Dietary supplement | CYP450 1A2 Inhibitors |
| Non selective beta blocker - Propranolol | Drug | Cirrhosis Beta Blockers |
| Ethanol | Dietary supplement | Alcohol |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2012.
Related trials for Healthy Subjects
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
Healthy Participants
Not yet recruiting
ACUTE EFFECTS OF HIGH-INTENSITY LASER THERAPY ON PAIN, MUSCLE STIFFNESS, AND GRIP STRENGTH IN HEALTHY ADULTS
Exercise-Induced Muscle Fatigue, Fatigue Recovery
RecruitingObservational study
Defining the Brain Phenotype of Children With Williams Syndrome
Williams Syndrome, Duplication
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 13C Methacetin Breath Test, Grape fruit juice and Non selective beta blocker - Propranolol in people with Healthy Subjects and Chronic Liver Disease, run by Hadassah Medical Organization 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 54 inclusion and 37 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: status not confirmed, as of the sponsor's last update on 28 Aug 2012. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.
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 28 Aug 2012.