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S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)

NCT06026865 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-03

No results posted yet for this study

Summary

The aim of this study is to investigate clinical effects (liver biochemistries, health-related quality of life, liver stiffness) and underlying mechanisms of hepatoprotection of S-adenosylmethionine in patients with primary sclerosing cholangitis. The study will be performed in a randomized and placebo-controlled fashion.

Conditions

  • Primary Sclerosing Cholangitis (PSC)

Interventions

DIETARY_SUPPLEMENT

S-Adenosyl-L-methionine (SAMe)

S-adenosyl-L-methionine 1200 mg/daily as 2400mg S-Adenosyl-L-methionine disulfate tosylate

OTHER

Placebo

Placebo of identical appearance, smell and taste, with the same schedule.

Sponsors & Collaborators

  • National Science Centre, Poland

    collaborator OTHER_GOV

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Piotr Milkiewicz, MD, PhD · Department of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-07-31
Completion
2026-06-01

Countries

  • Poland

Study Locations

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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 NCT06026865 on ClinicalTrials.gov