RecruitingNCT04685200

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

Sponsor

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

Enrollment

143 participants

Start Date

Mar 31, 2023

Study Type

OBSERVATIONAL

Conditions

Primary Sclerosing Cholangitis

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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This multidisciplinary research study is trying to understand the underlying mechanisms of primary sclerosing cholangitis (PSC), a chronic liver disease that causes progressive scarring and narrowing of the bile ducts. PSC is poorly understood and has no approved medical treatments. The study involves detailed blood tests, liver imaging, and endoscopic procedures, and also includes family members and household contacts as a comparison group. You may be eligible (as a PSC patient) if: - You are at least 18 years old - You have a confirmed PSC diagnosis based on blood tests and either MRCP or ERCP imaging showing large duct disease - You are willing to comply with study procedures and follow-up You may NOT be eligible if: - You have another cause of chronic liver disease in addition to PSC - You have had a liver transplant - You have decompensated liver disease (such as ascites, bleeding varices, or encephalopathy) - You have a current or suspected bile duct or liver cancer - You have severely abnormal blood counts or clotting tests - You take anticoagulant or antiplatelet medications (other than aspirin/NSAIDs) - You are pregnant or at risk of pregnancy without contraception Family members and household contacts of PSC patients are also eligible to enroll as a control group. Talk to your hepatologist about whether you meet all of the detailed lab criteria for safe study participation.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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