An observational study in Hepatobiliary Diseases, sponsored by University of Nebraska. Terminated at 1 site in United States. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by University of Nebraska · Observational
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.
Patients on the liver transplant list are continuously monitored during their hospitalization and are scheduled for follow-up visits for 12 months after their release post-surgery. Disease progression will be evaluated by monitoring MELD scores, survival, incidence of liver transplant, and incidence of complications related to hepatobiliary conditions such as fluid retention, GI bleeding, encephalopathy, and biliary stricture complications.
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 diseases in liver-transplant and non-liver-transplant patients, as monitored over a1-year period. The investigators working hypothesis is that patients' capabilities of sulfating BAs determine the progression of the disease.
613 studies on the registry are indexed under Digestive System Diseases; 118 are open to participants now.
This study's enrollment of 430 is above the median of 272 across 193 observational studies indexed under Digestive System Diseases.
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Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
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Healthy Controls: Subjects with no apparemt hepatobiliary diseases Patient Populaton: Subjects visiting the hepatology clinic in UNMC as part of their treatment of hepatobiliry diseases
Healthy Controls
Inclusion Criteria:
Exclusion Criteria:
Patient Population
Inclusion Criteria:
Exclusion Criteria:
Male or female, age 19-65, no apparent signs of hepatobiliary diseases
Male or female, age 19-65, visiting the UNMC hepatology clinic for treatment from hepatobiliary diseases
Urinary bile acid indexes
Bile acids (BAs), the end products of cholesterol metabolism, are synthesized in liver and excreted into bile, which flows to the small intestine via the bile duct. Most of the BAs are reabsorbed from the intestine into the portal circulation and undergo enterohepatic recirculation with minimal levels detected in urine and blood under normal conditions.
Time frame: Healthy controls: 4 visits over 28 days. Patients: urine collction at every visit as decided in their course of treatment
mayo model for end-stage liver disease score (MELD)
MELD score= 3.8\*loge (bilirubin \[mg/dL\]) + 11.2\*loge (INR) + 9.6\*loge (creatinine \[mg/dL\]).
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)
This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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