Clinical Trial: Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title:

Brief Summary:

The investigators hypothesize that the extent of sulfation of toxic BAs and their urinary elimination can be used as a biomarker to predict the severity and prognosis of hepatobiliary diseases. The investigators rationale in this project is that the discovery of biomarkers specific to liver injury would provide the foundation for a specific and non-invasive tool to evaluate disease prognosis, determine patients with higher risk of developing end-stage liver diseases, and determine patients with higher risk of recurrence of hepatobiliary complications after liver transplant. The investigators propose the following specific aims to test the investigators hypothesis:

Specific Aim #1: Establish a baseline of individual and total urinary BAs and BA-sulfates in healthy controls and patients with hepatobiliary diseases. A baseline reference of the average and distribution of the percentage of urinary BA-sulfates will be determined in healthy subjects and in patients with hepatobiliary diseases including chronic hepatitis C/B, alcoholic liver disease, hereditary, drug-induced, and autoimmune hepatobiliary diseases. The investigators working hypothesis is that patients' capability to sulfate total or specific BAs, as determined by the percentage of total or specific BAs excreted in the sulfate form, can predict the severity of hepatobiliary diseases, as determined by mayo model for end-stage liver disease (MELD) score and compensation status(compensated and decompensated). Patients with higher MELD score are considered to be at higher risk of developing severe hepatobiliary complications.

Specific Aim #2: Determine the relationship between BA sulfation and the progression of hepatobiliary diseases. This is an exploratory aim to collect preliminary data on the relationship between urinary BAs and the progression of hepatobiliary dis

Detailed Summary:
Sponsor: University of Nebraska

Current Primary Outcome: Urinary bile acid indexes [ Time Frame: Healthy controls: 4 visits over 28 days. Patients: urine collction at every visit as decided in their course of treatment ]

Original Primary Outcome: Urnianry bile acid indexes [ Time Frame: Healthy controls: 4 visits over 28 days. Patients: urine collction at every visit as decided in their course of treatment ]

Current Secondary Outcome: mayo model for end-stage liver disease score (MELD) [ Time Frame: Healthy controls: 1st visit only (1 week). Patients: every time a MELD score is required by hepatologists as partrt of their regular course of treatment (1 year) ]

Original Secondary Outcome: Same as current

Information By: University of Nebraska

Dates:
Date Received: August 31, 2010
Date Started: December 2010
Date Completion: December 2011
Last Updated: October 15, 2010
Last Verified: October 2010