MedTrace Logo

Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach

NCT04685200 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 143

Last updated 2026-05-20

No results posted yet for this study

Summary

Background:

Primary sclerosing cholangitis is a rare chronic liver disease. It affects the bile ducts of the

liver. It can result in bile duct infections, cirrhosis, cancer, and end stage liver disease. Researchers want to learn more about this disease.

Objective:

To understand the biological causes of primary sclerosing cholangitis.

Eligibility:

Adults age 18 and older who have primary sclerosing cholangitis.

Design:

Participants will be screened with a medical history, physical exam, and blood tests.

Participants will give blood, saliva, urine, and stool samples. They will have nasal swabs. They will complete surveys.

Participants will get an intravenous (IV) catheter. A plastic tube is inserted into an arm vein.

Participants will have a colonoscopy. A tube with a video camera at the end is inserted into the rectum.

Participants will have an upper endoscopy. A scope with a light and camera at its tip is used to look inside the upper digestive tract.

Participants will have a liver biopsy, entering through the chest wall or a neck vein. Blood is drawn from a blood vessel that carries blood to the liver. A liver tissue sample is taken.

Participants will have magnetic resonance imaging or spectroscopy. They will get a contrast agent through an IV.

Participants may have an optional bone marrow aspiration. A large needle is inserted into the hip to withdraw marrow.

Participants will have a liver ultrasound.

Participants will complete a 3-day food diary. They will have a nutrition assessment.

Participants may give contact details for people who live with them, to also take part in this study.

Participation will last for 12 months.

Conditions

  • Primary Sclerosing Cholangitis

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Theo Heller, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04685200 on ClinicalTrials.gov