RECRUITING

LGG Supplementation in Patients With AUD and ALD

Conditions

Alcohol Use Disorder Alcohol-associated Liver Disease AUD ALD AH TLFB LTDH AUDIT WHO Drinking Level Reduction Criteria MELD ALT AST ABIC Total Bilirubin Heavy Drinking Drinking Pattern AUD Domains Albumin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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). 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

Official Title

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

Quick Facts

Study Start:2022-06-01

Study Completion:2027-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05178069

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Breath alcohol concentration (BAC) equal to 0.00 when the participant signs the informed consent document. 2. Age between 21 and 65 years old (inclusive). 3. Willingness to receive trial treatment. 4. Ability to provide informed consent 5. Understanding that this is not an alcohol treatment study. 6. Heavy drinking. Men must consume ≥ 20 and women ≥ 14 standardized alcoholic beverages a week for the past 3 months. 7. Diagnosis of Alcohol Use Disorder using DSM V criteria. 8. 50 \<AST\<400 U/L; AST \> ALT; and ALT \< 200 U/L; total bilirubin \> 1.2 mg/dL 9. Model for End-Stage Liver Disease: 8 ≤ (MELD) ≤19. 10. Good health as confirmed by medical history, physical examination, ECG, laboratory tests and vital signs except for liver injury and AUD related history. 11. Provide contact information for someone who may be able to contact the subject in case of a missed appointment. 12. . Females of child-bearing potential must not be pregnant and must be using birth control	1. Current (last 12 months) DSM V diagnosis of dependence on any psychoactive substance other than alcohol or nicotine, 2. Positive urine drug screen at baseline for any illegal substance other than marijuana, 3. History of hospitalization for alcohol intoxication delirium, alcohol withdrawal delirium or seizure, 4. Participation in any research study for alcoholism treatment within 3 months prior to signing the informed consent, 5. Pharmacological treatment with naltrexone, acamprosate, topiramate, or disulfiram within 1 month prior to randomization, 6. Lifetime diagnosis based on DSM-V criteria of schizophrenia, bipolar disorder, or other psychosis, eating disorders; current or past year diagnosis of major depression 7. In the investigators' opinion, moderate to severe risk of suicide (e.g., active plan, or recent attempt in last 6 months), 8. Current use of psychotropic medications that cannot be discontinued, 9. Clinically significant medical abnormalities (apart from moderate ALD, MELD≤19), 10. Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) \>10, at screening for more than 3 days, 11. 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) 12. History of clinically significant hypotension (e.g., history of lipotimia and/or syncopal episodes) 13. History of adverse reactions to needle puncture, 14. Obesity (BMI ≥ 33.0 kg/m2), 15. Pregnancy; incarceration; inability to provide consent 16. Signs of systemic infection: Fever \> 38o C, positive blood or ascites cultures, on appropriate antibiotic therapy for \> 3 days within 3 days of inclusion 17. Acute gastrointestinal bleeding requiring \> 2 units blood transfusion within the previous 2 weeks 18. Undue risk from immunosuppression: Positive HBsAg; positive skin PPD skin test or history of treatment for tuberculosis; known HIV infection

Inclusion Criteria

Exclusion Criteria

1. Breath alcohol concentration (BAC) equal to 0.00 when the participant signs the informed consent document.
2. Age between 21 and 65 years old (inclusive).
3. Willingness to receive trial treatment.
4. Ability to provide informed consent
5. Understanding that this is not an alcohol treatment study.
6. Heavy drinking. Men must consume ≥ 20 and women ≥ 14 standardized alcoholic beverages a week for the past 3 months.
7. Diagnosis of Alcohol Use Disorder using DSM V criteria.
8. 50 \<AST\<400 U/L; AST \> ALT; and ALT \< 200 U/L; total bilirubin \> 1.2 mg/dL
9. Model for End-Stage Liver Disease: 8 ≤ (MELD) ≤19.
10. Good health as confirmed by medical history, physical examination, ECG, laboratory tests and vital signs except for liver injury and AUD related history.
11. Provide contact information for someone who may be able to contact the subject in case of a missed appointment.
12. . Females of child-bearing potential must not be pregnant and must be using birth control

1. Current (last 12 months) DSM V diagnosis of dependence on any psychoactive substance other than alcohol or nicotine,
2. Positive urine drug screen at baseline for any illegal substance other than marijuana,
3. History of hospitalization for alcohol intoxication delirium, alcohol withdrawal delirium or seizure,
4. Participation in any research study for alcoholism treatment within 3 months prior to signing the informed consent,
5. Pharmacological treatment with naltrexone, acamprosate, topiramate, or disulfiram within 1 month prior to randomization,
6. Lifetime diagnosis based on DSM-V criteria of schizophrenia, bipolar disorder, or other psychosis, eating disorders; current or past year diagnosis of major depression
7. In the investigators' opinion, moderate to severe risk of suicide (e.g., active plan, or recent attempt in last 6 months),
8. Current use of psychotropic medications that cannot be discontinued,
9. Clinically significant medical abnormalities (apart from moderate ALD, MELD≤19),
10. Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) \>10, at screening for more than 3 days,
11. 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)
12. History of clinically significant hypotension (e.g., history of lipotimia and/or syncopal episodes)
13. History of adverse reactions to needle puncture,
14. Obesity (BMI ≥ 33.0 kg/m2),
15. Pregnancy; incarceration; inability to provide consent
16. Signs of systemic infection: Fever \> 38o C, positive blood or ascites cultures, on appropriate antibiotic therapy for \> 3 days within 3 days of inclusion
17. Acute gastrointestinal bleeding requiring \> 2 units blood transfusion within the previous 2 weeks
18. Undue risk from immunosuppression: Positive HBsAg; positive skin PPD skin test or history of treatment for tuberculosis; known HIV infection

Contacts and Locations

Study Contact

Anjali Kumari, PhD

CONTACT

502-852-9054

anjali.kumari.1@louisville.edu

Steve Mahanes

CONTACT

502-852-1388

steve.mahanes@louisville.edu

Principal Investigator

Vatsalya Vatsalya, MD PhD

PRINCIPAL_INVESTIGATOR

Department of Medicine, University of Louisville

Craig J McClain, MD

STUDY_CHAIR

Department of Medicine, University of Louisville

Harsh Tiwari, MD

STUDY_DIRECTOR

University of Louisville

Study Locations (Sites)

University of Louisville Hospital

Louisville, Kentucky, 40202

United States

Collaborators and Investigators

Sponsor: University of Louisville

Vatsalya Vatsalya, MD PhD, PRINCIPAL_INVESTIGATOR, Department of Medicine, University of Louisville
Craig J McClain, MD, STUDY_CHAIR, Department of Medicine, University of Louisville
Harsh Tiwari, MD, STUDY_DIRECTOR, University of Louisville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-01

Study Completion Date2027-02-28

Study Record Updates

Study Start Date2022-06-01

Study Completion Date2027-02-28

Terms related to this study

Keywords Provided by Researchers

AUD
ALD
AH
TLFB
LTDH
AUDIT
WHO Drinking Level Reduction Criteria
MELD
ALT
AST
ABIC
Total Bilirubin
Heavy Drinking
Drinking Pattern
AUD Domains
Albumin

Additional Relevant MeSH Terms

Alcohol Use Disorder
Alcohol-associated Liver Disease