Actively Recruiting
Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12
143
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to follow all study procedures and availability for the entire study duration
- Male or nonpregnant female aged 18 years or older
- Confirmed diagnosis of PSC by biochemical tests and imaging showing large duct disease
- Agreement to follow lifestyle considerations during the study
You will not qualify if you...
- Pregnant or breastfeeding women or females of childbearing potential not using birth control
- History of other chronic liver diseases besides PSC
- Previous liver transplant
- Diagnosis of secondary sclerosing cholangitis
- Evidence of decompensated liver disease (ascites, variceal bleeding, encephalopathy, infection)
- History of liver or bile duct cancer or concerning lesions
- Elevated tumor markers (Ca-19-9 >130 U/microL or alpha-fetoprotein >200 ng/microL)
- Active systemic or localized infection
- Use of probiotics during the study
- Poorly controlled systemic diseases affecting function (e.g., diabetes, kidney failure, heart failure, severe COPD)
- History of gastrointestinal malignancy within 3 years unless low risk after curative surgery
- History of portal vein thrombosis
- Severe allergy to iodine or contrast agents not controlled by medication
- History of stomach or upper small bowel surgery including bariatric surgery
- Contraindications to anesthesia or sedation for endoscopy
- Use of anticoagulant or antiplatelet drugs except aspirin or NSAIDs
- Contraindications to MRI or MRCP
- Low neutrophil count (<1000/mm^3), low hemoglobin (<10 g/dl), or low platelet count (<50,000/mm^3)
- Abnormal blood clotting tests (INR ≥1.5, PTT ≥1.3 times control)
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Alaina K Magnani
CONTACT
T
Theo Heller, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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