Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases

NCT01200082 | Terminated

• 1 other identifier: 0487-10-EP
• Study Type: observational
• Target: 430
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Hepatobiliary Diseases

Keywords

chronic hepatitis C/B; alcoholic liver disease; primary biliary cirrhosis; primary sclerosing cholangitis; progressive familial intrahepatic cholestasis

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• mayo model for end-stage liver disease score (MELD)

  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)

Study Arms (2)

Healthy Controls

Male or female, age 19-65, no apparent signs of hepatobiliary diseases

Patients with hepatobiliary diseases

Male or female, age 19-65, visiting the UNMC hepatology clinic for treatment from hepatobiliary diseases

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male or female, age 19-65, no apparent signs of hepatobiliary diseases

You may not qualify if:

• Levels higher than 50, 56, 78 U/L for ALT, AST, and GGT, respectively.
• Patient Population
• Male or female, age 19-65, visiting the UNMC hepatology clinic for treatment from hepatobiliary diseases
• MELD score less than 6

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medial Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (3)

• Simko V, Michael S. Urinary bile acids in population screening for inapparent liver disease. Hepatogastroenterology. 1998 Sep-Oct;45(23):1706-14.

  PMID: 9840133 BACKGROUND

• Makino I, Hashimoto H, Shinozaki K, Yoshino K, Nakagawa S. Sulfated and nonsulfated bile acids in urine, serum, and bile of patients with hepatobiliary diseases. Gastroenterology. 1975 Mar;68(3):545-53.

  PMID: 1112456 BACKGROUND

• Alme B, Bremmelgaard A, Sjovall J, Thomassen P. Analysis of metabolic profiles of bile acids in urine using a lipophilic anion exchanger and computerized gas-liquid chromatorgaphy-mass spectrometry. J Lipid Res. 1977 May;18(3):339-62.

  PMID: 864325 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected from healthy volunteers at their 1st visit. Urine samples will be obtained from healthy controntrols and patients with hepatobiliary diseases over time.

MeSH Terms

Conditions

Digestive System Diseases; Liver Diseases, Alcoholic; Liver Cirrhosis, Biliary; Cholangitis, Sclerosing; Cholestasis, progressive familial intrahepatic 1

Condition Hierarchy (Ancestors)

Liver Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cholangitis

Study Officials

• Yazen M Alnouti, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 13, 2010
• Study Start: November 1, 2011
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

US (1)