NCT05178069 · University of Louisville
LGG Supplementation in Patients With AUD and ALD
(AUD+ALD)
What this study is about
To test the effectiveness of 6-month LGG compared to placebo in treating Alcoholic Use Disorder (AUD) and liver injury in Alcoholic Hepatitis (AH).
View original scientific description
To test the efficacy of 6-month LGG compared to placebo in treating Alcoholic Use Disorder (AUD) and liver injury in Alcoholic Hepatitis (AH).
Interventions
DRUG
: Placebo for Probiotic
Capsule manufactured without active ingredients.
DIETARY_SUPPLEMENT
Lactobacillus Rhamnosus GG
Probiotic nutritional supplement; Lactobacillus Rhamnosus G
Primary outcome measures
By lowering heavy drinking to meet the criteria on the responder definitions of abstinence, no heavy drinking days, WHO 1-level, and WHO 2-level reduction
Time frame: 180 days
Timeline Followback for past 180 days \[Unit: numerical frequency\], AUDIT \[Unit: numerical frequency\], monthly drinking questionnaire \[Unit: numerical frequency\]).
By reducing relapse episodes to minimal/absent incident level
Time frame: 180 days
(Unit: incident frequency).
By showing a significant positive effect on one or more of the underlying neurobehavioral domains.
Time frame: 180 days
Questionnaires: reward (reasons for heavy drinking questionnaire or RHDQ \[Unit: numerical frequency\]), craving (Penn Alcohol Craving Scale or PACS, \[Unit: numerical frequency\]; and obsessive compulsive drinking scale or OCDS \[Unit: numerical frequency\]), withdrawal (Clinical Institute Withdrawal Assessment Alcohol Scale Revised \[CIWA-AR\] or CIWA-AR \[Unit: numerical frequency\]), and reinforcement effects (Desires for Alcohol Questionnaire or DAQ \[Unit: numerical frequency\]).
By lowering a biochemical marker of alcohol intake
Time frame: 180 days
PeTH (Unit: μmol/L)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Breath alcohol concentration (BAC) equal to 0.00 when the participant signs the informed consent document.
- Age between 21 and 65 years old (inclusive).
- Willingness to receive trial treatment.
- Ability to provide informed consent
- Understanding that this is not an alcohol treatment study.
- Heavy drinking. Men must consume ≥ 20 and women ≥ 14 standardized alcoholic beverages a week for the past 3 months.
- Diagnosis of Alcohol Use Disorder using DSM V criteria.
- 50 \<AST\<400 U/L; AST \> ALT; and ALT \< 200 U/L; total bilirubin \> 1.2 mg/dL
- Model for End-Stage Liver Disease: 8 ≤ (MELD) ≤19.
- Good health as confirmed by medical history, physical examination, ECG, laboratory tests and vital signs except for liver injury and AUD related history.
- Provide contact information for someone who may be able to contact the subject in case of a missed appointment.
- . Females of child-bearing potential must not be pregnant and must be using birth control
Exclusion criteria
- Current (last 12 months) DSM V diagnosis of dependence on any psychoactive substance other than alcohol or nicotine,
- Positive urine drug screen at baseline for any illegal substance other than marijuana,
- History of hospitalization for alcohol intoxication delirium, alcohol withdrawal delirium or seizure,
- Participation in any research study for alcoholism treatment within 3 months prior to signing the informed consent,
- Pharmacological treatment with naltrexone, acamprosate, topiramate, or disulfiram within 1 month prior to randomization,
- Lifetime diagnosis based on DSM-V criteria of schizophrenia, bipolar disorder, or other psychosis, eating disorders; current or past year diagnosis of major depression
- In the investigators' opinion, moderate to severe risk of suicide (e.g., active plan, or recent attempt in last 6 months),
- Current use of psychotropic medications that cannot be discontinued,
- Clinically significant medical abnormalities (apart from moderate ALD, MELD≤19),
- Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) \>10, at screening for more than 3 days,
- Serious medical diseases, such as cancer, liver cirrhosis, pancreatitis, severe alcohol associated hepatitis, heart chronic failure, chronic kidney failure, chronic intestinal diseases (e.g., Crohn's disease), chronic neurological disorders (e.g., tardive dyskinesia, epilepsy, Parkinson's disease)
- History of clinically significant hypotension (e.g., history of lipotimia and/or syncopal episodes)
- History of adverse reactions to needle puncture,
- Obesity (BMI ≥ 33.0 kg/m2),
- Pregnancy; incarceration; inability to provide consent
- Signs of systemic infection: Fever \> 38o C, positive blood or ascites cultures, on appropriate antibiotic therapy for \> 3 days within 3 days of inclusion
- Acute gastrointestinal bleeding requiring \> 2 units blood transfusion within the previous 2 weeks
- Undue risk from immunosuppression: Positive HBsAg; positive skin PPD skin test or history of treatment for tuberculosis; known HIV infection
Where
- Louisville, Kentucky
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 31, 2025 · Source of record for eligibility and locations