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Can a common supplement help alcoholic cirrhosis patients live longer?

NCT ID NCT04250259

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a supplement called SAMe can improve liver function and reduce deaths in people with alcoholic cirrhosis. About 196 adults with mild to moderate cirrhosis will take SAMe or a placebo daily for 24 months. Researchers will measure liver health, gut function, and survival rates.

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) supplement
What this could lead to
If it works, this could point toward a simple supplement to improve liver function and lower death risk in people with alcoholic cirrhosis.
What could go wrong
This is a phase 2 trial with 196 participants, so results are still early. SAMe is a supplement, not a strong drug, and may not show clear benefit over 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 196 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Mar 2027

An estimate. End dates often move.

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 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 for patients with alcoholic cirrhosis 1. Evidence of cirrhosis as per clinical signs and/or noninvasive transient elastography (Fibroscan®), computed tomography, magnetic resonance imaging including MRI elastography compatible with cirrhosis and/or histopathology by biopsy and 2. subjects with clinical presentation either in Child Class A or B at the time of enrollment 3. individuals 18 to 70 years old and may or may not consume alcohol during study. Inclusion criteria for healthy control : ) individuals 18 to 70 years old (2) able to provide informed consent (3) subjects do not consume any alcohol or those who drink \< 50 grams per day on average in women and \< 80 grams per day on average in men (4) subjects are healthy without underlying acute or chronic medical conditions. Exclusion criteria for patients with alcoholic cirrhosis 1. Active infection as evidenced by positive urine culture, blood culture, or pneumonia, 2. Known co-existing infection with hepatitis C, hepatitis B, or HIV 3. Significant systemic or major illness including chronic obstructive pulmonary disease, congestive heart failure, and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study 4. Gastrointestinal bleeding within the prior 28 days3 5. Participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening 6. Women who are pregnant, may become pregnant, or nursing 7. Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of SAMe such as those with gastric bypass surgery 8. Subjects with history of/diagnosis of hepatocellular carcinoma 9. Members from the same family of study participant. This is based on the recent paper on the non-random sampling in randomized controlled trials4. We acknowledge that if we assign family members to identical treatment, randomization would not be totally correct; but if properly randomized, there is a chance that the members of the family might mix the pills. To avoid this issue and maintain the integrity of randomized blinded fashion, we will not include members from the same family into the study 10. Subjects with psychiatric illnesses such as bipolar disorders as SAMe may interfere with the levels of anti-psychotic drugs and 11. Subjects who are immunocompromised Exclusion criteria for all healthy control participants: 1. subjects with an active and serious medical disease 2. subjects with an infectious disease 3. consume any alcohol within 3 months before the study 4. subjects with localized or systemic infection

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Indiana University Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

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