N/A
N=30
Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling
Alcohol Consumption
Bottom Line
View on ClinicalTrials.gov: NCT02654236 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Change in Bile Salt Metabolism (C4 )Levels to Determine Effect of FXR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Placebo (Drug); 10 mg Obeticholic Acid (OCA) (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Suthat Liangpunsakul
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bile Salt Metabolism (C4 )Levels to Determine Effect of FXR |
— | — |
| PRIMARY Change in FGF19 Levels to Determine Effect of FXR |
— | — |
| SECONDARY Change in Fasting Serum Bile Salt Levels |
— | — |
| SECONDARY Change in Oxidative Stress Level by Measuring Malondialdehyde |
2.56; 2.79; 1.03; 1.54; 3.30; 1.38 | — |
| SECONDARY Change in CYP2E1 Activity by Measuring Chlorzoxazone Clearance |
— | — |
| SECONDARY Change in Gut Permeability Through Lactulose/Mannitol Test |
0.05; 0.04; 0.04; 0.05; 0.07; 0.05 | — |
| SECONDARY Change in Bacterial Translocation Through Measures of Plasma LPS |
40.22; 58.73; 58.28; 47.84; 47.0; 19.99 | — |
| SECONDARY Change in Intestinal Inflammation by Measuring Stool Calprotectin |
— | — |
| SECONDARY Change in Activation of Innate Immunity Through Measures of TNF-alpha |
6.53; 8.99; 6.91; 6.36; 7.97; 2.89 | — |
| SECONDARY Change in Bacterial Translocation Through Measures of Serum sCD14 |
2.56; 3.05; 2.09; 2.28; 2.28; 1.38 | — |
| SECONDARY Change in Activation of Innate Immunity Through Measures of IL-6 |
— | — |
| SECONDARY Change in Activation of Innate Immunity Through Measures of IL-8 |
— | — |
| SECONDARY Change in Activation of Innate Immunity Through Measures of IL-1 |
1.90; 1.78; 1.77; 1.76; 1.45; 1.07 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Individuals ≥ 21 to 65 years old
- Able to provide informed consent & negative urine pregnancy test where appropriate
- Healthy controls must have not consumed any alcohol within 3 months prior to the screening visit
- Heavy alcohol drinking is defined as > 40 grams per day on average in women and > 60 grams per day on average in men for a minimum of 6 months
- Women of child bearing potential should be willing to practice contraception throughout the treatment period
Exclusion Criteria
- Active infection as evidenced by positive urine culture, blood culture, or pneumonia
- Serum creatinine > 1.5 mg/dL
- Known co-existing infection with hepatitis C, hepatitis B, or HIV
- Significant systemic or major illness including COPD, CHF and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study.
- Participation in another investigational drug, biologic, or medical device trial within 30 days prior to Screening
- Previous history of jaundice or signs of liver diseases such as spider angiomata, ascites, or history of esophageal varices or hepatic encephalopathy
- Total bilirubin > 2 mg/dl and INR > 1.5 Page 20 of 37
- Women who are pregnant or nursing
- Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine. Patients who have undergone gastric bypass procedures will be excluded (gastric lap band is acceptable).
- Subjects who are taking warfarin
Data sourced from ClinicalTrials.gov (NCT02654236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.