¹³C-Methacetin Breath Test (MBT) Methodology Study

NCT01205074 | Unknown Phase 2

• 1 other identifier: METH-EX-610- HMO - CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects; Chronic Liver Disease; Cirrhosis

Keywords

Patients with chronic liver disease and cirrhosis

Study Arms (6)

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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Meridian Bioscience, Inc.: collaborator

Study Sites (1)

Liver Unit Hadassah Medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Fibrosis

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 20, 2010
• Study Start: September 1, 2010
• Last Updated: August 28, 2012

Record last verified: 2011-06

Locations

IL (1)