Effect of S-Adenosylmethionine (SAMe) in Patients with Alcoholic Cirrhosis

Study on Dietary Supplement Effects in Liver Disease

S
Suthat Liangpunsakul, MD

Primary Investigator

Enrolling By Invitation
18 years - 70 years
All
98 participants needed
1 Location

Brief description of study

The proposed of this randomized, double blinded, placebo-controlled study is to assess the effect of SAMe compared to placebo in patients with alcoholic cirrhosis Child Class A and B. The primary objective of the study is to test relationship between SAMe (S-adenosylmethionine) supplement on liver function. The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.The main purpose of this study is to see whether SAMe, a dietary supplement, will effectively help patients with alcoholic cirrhosis by improving liver function.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Research personnel will contact potential case study subjects via phone call or face-to-face in clinic.

Detailed description of study

This study will include both patients diagnosed with alcoholic cirrhosis and healthy volunteers.

Both groups will complete screening, to include: background information; family history of alcoholism; medical history; tobacco and alcohol use; dietary questionnaire; AUDIT (routine medical screening questionnaire); vital signs; height/weight; and collection of blood, urine, and stool samples.

If eligible, participants will then return 14-21 days later to complete review of current medications; liver stiffness measurement; blood, urine, and stool sample collection. Healthy volunteer participation ends at this point. Patients with cirrhosis will be randomly assigned to either take SAMe or a placebo pill.

Participants will take study medicine (SAMe/placebo) twice per day - 2 tablets in the morning 30 mintues prior to a meal, and 1 tablet in the evening prior to dinner. This will continue for 24 months.

Return study visits will be conducted at 1 month, 4 months, 8 months, 12 months, 16 months, and 20 months later. Visits will include: questionnaires; side effect reporting; review of current medication; blood, urine, and stool sample collection. At month 12, liver stiffness measurement will be repeated. 

The final study visit will take place after 24 months and will include: questionnaires; side effect reporting; review of current medication; liver stiffness measurement; blood, urine, and stool sample collection.

Participants will receive $40 per study visit (2 visits for healthy volunteers and 8 for cirrhosis patients).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Alcoholic Cirrhosis, Healthy
  • Age: 18 years - 70 years
  • Gender: All

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

This study investigates the effects of a dietary supplement on liver function in people with alcoholic cirrhosis. Alcoholic cirrhosis is a liver condition caused by long-term alcohol use, which leads to scarring and poor liver function. The purpose of this study is to compare the effects of the supplement to a placebo, which is a substance with no active medicine, to see if it can improve liver health.

Participants will undergo various procedures, including health screenings and tests like blood, urine, and stool sample collection. Those with cirrhosis will be randomly assigned to take either the supplement or a placebo twice daily for 24 months. Healthy volunteers will participate in initial screenings but will not take the supplement. Participants will have regular check-ups to monitor their health and the effects of the supplement.

  • Who can participate: Participants must be between 18 and 70 years old. Those with alcoholic cirrhosis need evidence of the condition and be in Child Class A or B, while healthy volunteers must not have serious medical conditions and should not consume significant alcohol.
  • Study details: Participants with cirrhosis will take the study supplement or placebo twice daily. Healthy volunteers will complete initial screenings but will not take the supplement. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
  • Study timelines and visits: The study will last 24 months. The study requires 8 visits.
Updated on 17 Sep 2025. Study ID: GI-IIR-SAME, 1912233853
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only