¹³C-Methacetin Breath Test (MBT) Methodology Study
|ClinicalTrials.gov Identifier: NCT01205074|
Recruitment Status : Unknown
Verified June 2011 by Hadassah Medical Organization.
Recruitment status was: Active, not recruiting
First Posted : September 20, 2010
Last Update Posted : August 28, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects Chronic Liver Disease Cirrhosis||Device: 13C Methacetin Breath Test Dietary Supplement: Grape fruit juice Drug: Non selective beta blocker - Propranolol Dietary Supplement: Ethanol||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||¹³C-Methacetin Breath Test (MBT) Methodology Study|
|Study Start Date :||September 2010|
|Experimental: Repeatability||Device: 13C Methacetin Breath Test|
|Experimental: COPD||Device: 13C Methacetin Breath Test|
|Experimental: Smokers||Device: 13C Methacetin Breath Test|
|Experimental: CYP450 1A2 Inhibitors||Device: 13C Methacetin Breath Test Dietary Supplement: Grape fruit juice|
|Experimental: Cirrhosis Beta Blockers||Device: 13C Methacetin Breath Test Drug: Non selective beta blocker - Propranolol|
|Experimental: Alcohol||Device: 13C Methacetin Breath Test Dietary Supplement: Ethanol|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205074
|Liver Unit Hadassah Medical Center|
|Jerusalem, Israel, 91120|