TerminatedNot Applicable

Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases

Stopped: Institutional Review Board approval not maintained

United States430 participantsStarted 2011-11

Plain-language 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. 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.

Who can participate

Age range

19 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Healthy Controls Inclusion Criteria: * Male or female, age 19-65, no apparent signs of hepatobiliary diseases Exclusion Criteria: * Levels higher than 50, 56, 78 U/L for ALT, AST, and GGT, respectively. Patient Population Inclusion Criteria: * Male or female, age 19-65, visiting the UNMC hepatology clinic for treatment from hepatobiliary diseases Exclusion Criteria: * MELD score less than 6

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Urinary bile acid indexes

Timeframe: Healthy controls: 4 visits over 28 days. Patients: urine collction at every visit as decided in their course of treatment

Trial details

NCT IDNCT01200082

SponsorUniversity of Nebraska

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-09-02

View on ClinicalTrials.gov More Hepatobiliary Diseases trials