NCT06026865

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

Clinical Effect and Molecular Mechanisms of Action of S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is designed as a randomised, double-blind, placebo-controlled trial. Eighty participants will be randomized in 1:1 ratio to one of two arms of the study: Intervention or Placebo. Participants in Intervention Group will be treated with S-adenosyl-L-methionine 1200 mg/daily in tablets in two divided doses (800mg in the morning and 400mg midday) over the period of 6 months. Patients in Placebo Group will receive a placebo of identical appearance, smell and taste, with the same schedule. Participants will be monitored in out-patient clinic at baseline, interim visits at weeks: 4, 12, end of treatment at 24 weeks and follow-up visit after 4-6 weeks wash-out period. Treatment adherence, adverse events, serum biochemistry and health related quality of life will be assessed at each visit. Liver fibrosis will be measured with transient elastography at baseline and at the end of treatment.

Conditions

• Primary Sclerosing Cholangitis (PSC)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-07-31
• Completion: 2026-06-01
• First posted: 2023-09-07
• Last updated: 2025-04-03

Locations

1 site across 1 country: Poland