LGG Supplementation in Patients With AUD and ALD
AUD+ALD
Lactobacillus Rhamnosus GG: A Novel Probiotic Therapy for Treating Alcohol Use Disorder
Sponsor study identifier
Secondary identifiers
NIH
interventional
60
1 country
1
Study Start
June 1, 2022
Actual (reported)Primary Completion
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 9, 2021
Actual (reported)January 5, 2022
Actual (reported)June 1, 2022
Actual (reported)August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 28, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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 \[Unit: numerical frequency\]).
180 days
By reducing relapse episodes to minimal/absent incident level
(Unit: incident frequency).
180 days
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 \[Unit: numerical frequency\]).
Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.
Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.
Capsule manufactured without active ingredients.
Probiotic nutritional supplement; Lactobacillus Rhamnosus G
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
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.
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.
Vatsalya Vatsalya, MD
Department of Medicine, University of Louisville
Craig J McClain, MD
Department of Medicine, University of Louisville
Harsh Tiwari, MD
University of Louisville
First Submitted
November 9, 2021
First Posted
January 5, 2022
Study Start
June 1, 2022
Actual (reported)Primary Completion
Clinical Trial of Rybelsus (Semaglutide) Among Adults With Alcohol Use Disorder (AUD)
180 days
By lowering a biochemical marker of alcohol intake
PeTH (Unit: μmol/L)
180 days
By significantly improving liver related and clinical markers
180 days
By substantially improving the overall health as assessed by the patient reported outcomes
180 days
By lowering frequency and intensity of treatment/disease based adverse effects (AE).
180 days
To determine the therapeutic-mechanistic markers of gut-brain axis, pro-inflammatory activity in AUD
180 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
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.
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.
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.
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.
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.
August 31, 2026
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 31, 2025
Record last verified: 2025-10
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