Chronic Liver Disease, Cirrhosis, Healthy Subjects
Conditions
Keywords
Patients with chronic liver disease and cirrhosis
Brief 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. 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. V. 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.
Interventions
DEVICE13C Methacetin Breath Test
DIETARY_SUPPLEMENTGrape fruit juice
DRUGNon selective beta blocker - Propranolol
DIETARY_SUPPLEMENTEthanol
Sponsors
Meridian Bioscience, Inc.
Hadassah Medical Organization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria - General * 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.
Exclusion criteria
- 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.
Countries
Israel
Outcome results
None listed