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Can a common supplement ease a rare liver disease?

NCT ID NCT06026865

Disease control Sponsor: Medical University of Warsaw Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial tests whether a dietary supplement called SAMe can improve liver health and quality of life in people with primary sclerosing cholangitis (PSC), a chronic liver disease. Participants will receive either SAMe or a placebo for a period, and researchers will measure changes in liver enzymes, liver stiffness, fatigue, and other symptoms. The study aims to uncover whether SAMe offers any protective benefits for the liver and how it might work at a molecular level.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
S-adenosylmethionine (SAMe), a dietary supplement, taken as 1200 mg daily
What this could lead to
If SAMe proves effective, it could offer a new way to ease symptoms and slow liver damage in people with primary sclerosing cholangitis, potentially improving their daily lives.
What could go wrong
This is an early-stage trial with a modest number of participants, so results may not be conclusive. SAMe is a supplement, and its benefits for PSC are not yet established; it may not outperform a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Sep 2023

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Cholangitis, Sclerosing primary sclerosing cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary sclerosing cholangitis (PSC)

Contacts and locations

Locations

  • Department of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw

    Warsaw, Poland

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