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

Primary Sclerosing Cholangitis (PSC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06026865
• Other study ID #: 2020/39/O/NZ5/03594
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: September 2023
• Source: Medical University of Warsaw
• Contact: Emil Bik, MD
• Phone: +48 22 599 16 62
• Email: emil.bik[@]uckwum.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• primary sclerosing cholangitis fulfilling EASL criteria;

• age: 18 - 75 years;

• treatment with ursodeoxycholic acid (UDCA) in a dose of 13-15mg/kg b.w. for at least 6 months.

Exclusion Criteria:

• inability to give informed consent;

• patients with other forms of chronic liver diseases;

• decompensated liver cirrhosis (Child-Pugh class B-C);

• patients with PSC who underwent stenting of their biliary tree within 6 months;

• other diseases or states that can affect quality of life and mood: decompensated diabetes mellitus, renal insufficiency requiring dialyses, malignancy, heart failure = New York Heart Association (NYHA) II, organ transplantation, known HIV infection, rheumatoid arthritis, asthma, psychiatric disorders;

• treatment with: steroids, statins, rifampicin, antidepressants;

• pregnant or breastfeeding women;

• history of hypersensitivity reactions to S-adenosylmethionine;

• any other condition, which in the opinion of the investigators would impede the patient's participation or compliance in the study.

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis (PSC)

Intervention

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.

Locations

Country	Name	City	State
Poland	Department of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	National Science Centre, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in liver biochemistries	Change in levels of liver enzymes (Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyltransferase, Alkaline Phosphatase)	6 months
Primary	Change in Health-related Quality of Life	Change in severity of chronic fatigue and other aspects of health-related quality of life assessed by questionnaire SF-36 (36-Item Short Form Survey).	6 months
Primary	Change in PSC-related Quality of Life	Change in severity of chronic fatigue and other aspects of health-related quality of life assessed by questionnaire PBC-40.	6 months
Primary	Change in Quality of Life	Change in severity of generalized anxiety disorder assessed by questionnaire GAD-7 (General Anxiety Disorder-7).	6 months
Primary	Change in pruritus severity	Change in pruritus severity on the Visual Analogue Scale (VAS) - 0 (no pruritus) to 10 (worst pruritus).	6 months
Primary	Change in liver stiffness	Change in liver stiffness on liver elastography (measured in kPa)	6 months
Secondary	Molecular assesment of hepatoprotective properties of SAMe	Assessment of changes in antioxidant defence system (assessed as plasma MDA, SOD2, FGF-19, TNF-a, IL6, IL10, TGFß, INF?, homocysteine concentrations).	6 months