The main purpose of this study is to see whether heavy drinking will interfere with a specific pathway, called FXR signaling in the liver. The abnormality of this pathway may lead to liver injury in some patients who drink heavily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
30
1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 4 weeks.
Indiana University
Indianapolis, Indiana, United States
Change in Bile Salt Metabolism (C4 )Levels to Determine Effect of FXR
Time frame: Baseline to 28 days
Change in FGF19 Levels to Determine Effect of FXR
Time frame: Baseline to 28 days
Change in Fasting Serum Bile Salt Levels
Time frame: Baseline to 28 days
Change in Oxidative Stress Level by Measuring Malondialdehyde
Time frame: Baseline to 28 days
Change in CYP2E1 Activity by Measuring Chlorzoxazone Clearance
Time frame: Baseline to 28 days
Change in Gut Permeability Through Lactulose/Mannitol Test
This is the measurement to quantify two non-metabolized sugar molecules-lactulose and mannitol-to determine the gut permeability
Time frame: Baseline to 28 days
Change in Bacterial Translocation Through Measures of Plasma LPS
Time frame: Baseline to 28 days
Change in Intestinal Inflammation by Measuring Stool Calprotectin
Time frame: Baseline to 28 days
Change in Activation of Innate Immunity Through Measures of TNF-alpha
Time frame: Baseline to 28 days
Change in Bacterial Translocation Through Measures of Serum sCD14
Time frame: Baseline to 28 days
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Change in Activation of Innate Immunity Through Measures of IL-6
Time frame: Baseline to 28 days
Change in Activation of Innate Immunity Through Measures of IL-8
Time frame: Baseline to 28 days
Change in Activation of Innate Immunity Through Measures of IL-1
Time frame: Baseline to 28 days