AzTrials
AzTrials

Alcohol Use DisorderPhase 2AUD+ALDNCT05178069

LGG Supplementation in Patients With AUD and ALD

A Phase 2 study testing Lactobacillus Rhamnosus GG in people with Alcohol Use Disorder and Alcohol-associated Liver Disease, run by University of Louisville at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To test the efficacy of 6-month LGG compared to placebo in treating Alcoholic Use Disorder (AUD) and liver injury in Alcoholic Hepatitis (AH). And to evaluate the effects of LGG treatment compared to placebo on therapeutic-mechanistic markers of the gut-brain axis and pro-inflammatory activity in patients with AUD and… Read more about this study

Who is it for?
Ages 21 to 65 years
What is being tested?
Lactobacillus Rhamnosus GG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
1 Jun 2022to 28 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Amber Jackson, BS CCRP contact

502-852-2905

amber.jackson.1@louisville.edu

Steve Mahanes contact

502-852-1388

steve.mahanes@louisville.edu

United States1 site, 1 recruiting

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

    Vatsalya Vatsalya, MD, PgD, MSc, MS, FRSM, 502-952-8928, v0vats01@louisville.edu

    Steve Mahanes, 5028521388, steve.mahanes@louisville.edu

    Recruiting

Other trials in United States

About this study

Official title: Lactobacillus Rhamnosus GG: A Novel Probiotic Therapy for Treating Alcohol Use Disorder

To test the efficacy of 6-month LGG compared to placebo in treating Alcoholic Use Disorder (AUD) and liver injury in Alcoholic Hepatitis (AH). And to evaluate the effects of LGG treatment compared to placebo on therapeutic-mechanistic markers of the gut-brain axis and pro-inflammatory activity in patients with AUD and moderate AH

Read the detailed description

Aim. 1: To test the efficacy of 6-month LGG compared to placebo in treating AUD: (1a) by lowering heavy drinking (1b) by reducing relapse episodes to minimal/absent incident level; (1c) by showing a significant positive effect on one or more of the underlying neurobehavioral domain, and (1d) by lowering a biochemical marker of alcohol intake.

Aim. 2: To test if 6-month LGG treatment compared to placebo will improve the symptoms and liver injury in AH: (2a) by significantly improving liver related tests (AST, ALT, AST:ALT, albumin, bilirubin and INR; K18M65 and K18M30) and clinical severity/prognostic markers (MELD, Maddrey); (2b) by substantially improving the overall health as assessed by the patient reported outcomes (Quality of Life [QOL] scale, and drinker inventory of consequences [DrInC]); and (2c) by lowering frequency and intensity of treatment/disease based adverse effects (AE).

Aim. 3: To evaluate the effects of LGG treatment compared to placebo on therapeutic-mechanistic markers of gut-brain axis and pro-inflammatory activity in patients with AUD and moderate AH: (3a) by identifying the blood biomarkers of gut-barrier dysfunction and endotoxemia, and inflammation; (3b) by determining the therapeutic targets of LGG involved in the gut-brain axis of AUD using LC-MS metabolomic fecal assays (candidate markers of gut-dysfunction associated neurotransmitters); and (3c) by validating the efficacy of LGG treatment vs. placebo to lower inflammation using an ex-vivo design.

Being tested
: Placebo for Probiotic, Lactobacillus Rhamnosus GG
Keywords
AUD, ALD, AH, TLFB, LTDH, AUDIT, WHO Drinking Level Reduction Criteria, MELD, ALT, AST, ABIC, Total Bilirubin, Heavy Drinking, Drinking Pattern, AUD Domains, Albumin
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • : Placebo for ProbioticDrug

    Also called Dummy capsule

    Capsule manufactured without active ingredients.

  • Lactobacillus Rhamnosus GGDietary supplement

    Also called Culturelle

    Probiotic nutritional supplement; Lactobacillus Rhamnosus G

Study groups in NCT05178069
Study groupRoleWhat they receive
Placebo Comparator: Placebo for ProbioticPlacebo comparatorPlacebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.
Receives: Drug: : Placebo for Probiotic
Active Comparator: Lactobacillus Rhamnosus GGActive comparatorDietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.
Receives: Dietary Supplement: Lactobacillus Rhamnosus GG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Timeline Followback for past 180 days [Unit: numerical frequency], AUDIT [Unit: numerical frequency], monthly drinking questionnaire [Unit: numerical frequency]).

    Measured: 180 days

  2. By reducing relapse episodes to minimal/absent incident level

    (Unit: incident frequency).

    Measured: 180 days

  3. By showing a significant positive effect on one or more of the underlying neurobehavioral domains.

    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]).

    Measured: 180 days

  4. By lowering a biochemical marker of alcohol intake

    PeTH (Unit: μmol/L)

    Measured: 180 days

Secondary outcomes (3)

  1. By significantly improving liver related and clinical markers

    Liver markers: Aspartate transaminases or AST (Unit: IU/L), Alanine Transaminases or ALT (Unit: IU/L), Albumin (Unit: g/dL), Total bilirubin (Unit: mg/dL), Creatinine (Unit: mg/dL), and INR (Unit: numerical), AST:ALT ratio (numerical unit), Prothrombin Time or PT (Unit: seconds).

    Clinical marker: Model For End-Stage Liver Disease or MELD ([=0.957 × ln(Cr) + 0.378 × ln(bilirubin) + 1.120 × ln(INR) + 0.643]. Unit: numerical), Maddrey's Discriminant Function for Alcoholic Hepatitis or Maddrey DF ([=4.6 * (Pt's PT - Control PT) + TBili]. Unit: numerical).

    Laboratory markers: K18M65 and K18M30 (Unit for both: IU/L).

    Measured: 180 days

  2. By substantially improving the overall health as assessed by the patient reported outcomes

    Quality of Life or QOL scale [Unit: numerical frequency], Drinker inventory of consequences or DrInC [unit: numerical frequency].

    Measured: 180 days

  3. By lowering frequency and intensity of treatment/disease based adverse effects (AE).

    Incident frequency of AE [Unit: numerical], Severity Scale (AE/SAE (Unit: 1-5).

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2022
  2. Study start1 Jun 2022
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Time by Treatment
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05178069
Sponsor's protocol ID
21.1038
Other IDs
K23AA029198
Acronym
AUD+ALD
Status last verified
Oct 2025
First submitted
9 Nov 2021
Last updated
31 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • McClain CJ, Vatsalya V, Mitchell MC. Keratin-18: Diagnostic, Prognostic, and Theragnostic for Alcohol-Associated Hepatitis. Am J Gastroenterol. 2021 Jan 1;116(1):77-79. doi: 10.14309/ajg.0000000000001042.

    PubMed 33306505

  • Gala KS, Vatsalya V. Emerging Noninvasive Biomarkers, and Medical Management Strategies for Alcoholic Hepatitis: Present Understanding and Scope. Cells. 2020 Feb 25;9(3):524. doi: 10.3390/cells9030524.

    PubMed 32106390

  • Vatsalya V, Cave MC, Kong M, Gobejishvili L, Falkner KC, Craycroft J, Mitchell M, Szabo G, McCullough A, Dasarathy S, Radaeva S, Barton B, McClain CJ. Keratin 18 Is a Diagnostic and Prognostic Factor for Acute Alcoholic Hepatitis. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2046-2054. doi: 10.1016/j.cgh.2019.11.050. Epub 2019 Dec 4.

    PubMed 31811953

  • Zhou Y, Vatsalya V, Gobejishvili L, Lamont RJ, McClain CJ, Feng W. Porphyromonas gingivalis as a Possible Risk Factor in the Development/Severity of Acute Alcoholic Hepatitis. Hepatol Commun. 2018 Dec 14;3(2):293-304. doi: 10.1002/hep4.1296. eCollection 2019 Feb.

    PubMed 30766965

  • Gowin JL, Sloan ME, Stangl BL, Vatsalya V, Ramchandani VA. Vulnerability for Alcohol Use Disorder and Rate of Alcohol Consumption. Am J Psychiatry. 2017 Nov 1;174(11):1094-1101. doi: 10.1176/appi.ajp.2017.16101180. Epub 2017 Aug 4.

    PubMed 28774194

  • Vatsalya V, Gowin JL, Schwandt ML, Momenan R, Coe MA, Cooke ME, Hommer DW, Bartlett S, Heilig M, Ramchandani VA. Effects of Varenicline on Neural Correlates of Alcohol Salience in Heavy Drinkers. Int J Neuropsychopharmacol. 2015 Jul 25;18(12):pyv068. doi: 10.1093/ijnp/pyv068.

    PubMed 26209857

  • Vatsalya V, Gala KS, Hassan AZ, Frimodig J, Kong M, Sinha N, Schwandt ML. Characterization of Early-Stage Alcoholic Liver Disease with Hyperhomocysteinemia and Gut Dysfunction and Associated Immune Response in Alcohol Use Disorder Patients. Biomedicines. 2020 Dec 24;9(1):7. doi: 10.3390/biomedicines9010007.

    PubMed 33374263

  • Vatsalya V, Kong M, Marsano LM, Kurlawala Z, Chandras KV, Schwandt ML, Ramchandani VA, McClain CJ. Interaction of Heavy Drinking Patterns and Depression Severity Predicts Efficacy of Quetiapine Fumarate XR in Lowering Alcohol Intake in Alcohol Use Disorder Patients. Subst Abuse. 2020 Sep 9;14:1178221820955185. doi: 10.1177/1178221820955185. eCollection 2020.

    PubMed 32963470

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lactobacillus Rhamnosus GG in people with Alcohol Use Disorder and Alcohol-associated Liver Disease, run by University of Louisville at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amber Jackson, BS CCRP (502-852-2905, amber.jackson.1@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05178069, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in