NCT01205074

¹³C-Methacetin Breath Test (MBT) Methodology Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	13C Methacetin Breath Test
DIETARY_SUPPLEMENT	Grape fruit juice
DRUG	Non selective beta blocker - Propranolol
DIETARY_SUPPLEMENT	Ethanol

Timeline

• Start date: 2010-09-01
• First posted: 2010-09-20
• Last updated: 2012-08-28

Locations

1 site across 1 country: Israel