[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100452942":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":46,"locations":57,"responsibleParty":79,"collaborators":82,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":51,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":60,"whyStopped":51,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"University of Louisville","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo Comparator: Placebo for Probiotic","PLACEBO_COMPARATOR","Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.",[13],"Drug: : Placebo for Probiotic",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Comparator: Lactobacillus Rhamnosus GG","ACTIVE_COMPARATOR","Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.",[19],"Dietary Supplement: Lactobacillus Rhamnosus GG",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG",": Placebo for Probiotic","Capsule manufactured without active ingredients.",[9],[27],"Dummy capsule",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DIETARY_SUPPLEMENT","Lactobacillus Rhamnosus GG","Probiotic nutritional supplement; Lactobacillus Rhamnosus G",[15],[34],"Culturelle",[36,40,43],{"name":37,"affiliation":38,"role":39},"Vatsalya Vatsalya, MD","Department of Medicine, University of Louisville","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":38,"role":42},"Craig J McClain, MD","STUDY_CHAIR",{"name":44,"affiliation":5,"role":45},"Harsh Tiwari, MD","STUDY_DIRECTOR",[47,53],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"Amber Jackson, BS CCRP","CONTACT","502-852-2905",null,"amber.jackson.1@louisville.edu",{"name":54,"role":49,"phone":55,"phoneExt":51,"email":56},"Steve Mahanes","502-852-1388","steve.mahanes@louisville.edu",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"University of Louisville Hospital","RECRUITING","Louisville","Kentucky","40202","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-85.75941,38.25424,{"lat":70,"lon":69},[73,77],{"name":74,"role":49,"phone":75,"phoneExt":51,"email":76},"Vatsalya Vatsalya, MD, PgD, MSc, MS, FRSM","502-952-8928","v0vats01@louisville.edu",{"name":54,"role":49,"phone":78,"phoneExt":51,"email":56},"5028521388",{"type":39,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"Vatsalya Vatsalya","Faculty in Medicine",[83],{"name":84,"class":85},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100452942","phase-2-lgg-supplementation-in-patients-with-aud-and-ald-100452942",false,"NCT05178069","LGG Supplementation in Patients With AUD and ALD","Lactobacillus Rhamnosus GG: A Novel Probiotic Therapy for Treating Alcohol Use Disorder","AUD+ALD","Inclusion Criteria:\n\n1. Breath alcohol concentration (BAC) equal to 0.00 when the participant signs the informed consent document.\n2. Age between 21 and 65 years old (inclusive).\n3. Willingness to receive trial treatment.\n4. Ability to provide informed consent\n5. Understanding that this is not an alcohol treatment study.\n6. Heavy drinking. Men must consume ≥ 20 and women ≥ 14 standardized alcoholic beverages a week for the past 3 months.\n7. Diagnosis of Alcohol Use Disorder using DSM V criteria.\n8. 50 \\\u003CAST\\\u003C400 U\u002FL; AST \\> ALT; and ALT \\\u003C 200 U\u002FL; total bilirubin \\> 1.2 mg\u002FdL\n9. Model for End-Stage Liver Disease: 8 ≤ (MELD) ≤19.\n10. Good health as confirmed by medical history, physical examination, ECG, laboratory tests and vital signs except for liver injury and AUD related history.\n11. Provide contact information for someone who may be able to contact the subject in case of a missed appointment.\n12. . Females of child-bearing potential must not be pregnant and must be using birth control\n\nExclusion Criteria:\n\n1. Current (last 12 months) DSM V diagnosis of dependence on any psychoactive substance other than alcohol or nicotine,\n2. Positive urine drug screen at baseline for any illegal substance other than marijuana,\n3. History of hospitalization for alcohol intoxication delirium, alcohol withdrawal delirium or seizure,\n4. Participation in any research study for alcoholism treatment within 3 months prior to signing the informed consent,\n5. Pharmacological treatment with naltrexone, acamprosate, topiramate, or disulfiram within 1 month prior to randomization,\n6. Lifetime diagnosis based on DSM-V criteria of schizophrenia, bipolar disorder, or other psychosis, eating disorders; current or past year diagnosis of major depression\n7. In the investigators' opinion, moderate to severe risk of suicide (e.g., active plan, or recent attempt in last 6 months),\n8. Current use of psychotropic medications that cannot be discontinued,\n9. Clinically significant medical abnormalities (apart from moderate ALD, MELD≤19),\n10. Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) \\>10, at screening for more than 3 days,\n11. 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)\n12. History of clinically significant hypotension (e.g., history of lipotimia and\u002For syncopal episodes)\n13. History of adverse reactions to needle puncture,\n14. Obesity (BMI ≥ 33.0 kg\u002Fm2),\n15. Pregnancy; incarceration; inability to provide consent\n16. Signs of systemic infection: Fever \\> 38o C, positive blood or ascites cultures, on appropriate antibiotic therapy for \\> 3 days within 3 days of inclusion\n17. Acute gastrointestinal bleeding requiring \\> 2 units blood transfusion within the previous 2 weeks\n18. Undue risk from immunosuppression: Positive HBsAg; positive skin PPD skin test or history of treatment for tuberculosis; known HIV infection","ALL","21 Years","65 Years",{"count":98,"type":99},60,"ESTIMATED","INTERVENTIONAL",[102],"PHASE2","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",[105,106],"Alcohol Use Disorder","Alcohol-associated Liver Disease",[108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123],"AUD","ALD","AH","TLFB","LTDH","AUDIT","WHO Drinking Level Reduction Criteria","MELD","ALT","AST","ABIC","Total Bilirubin","Heavy Drinking","Drinking Pattern","AUD Domains","Albumin","2025-10-29",{"date":126,"type":127},"2025-10-31","ACTUAL",{"date":129,"type":127},"2022-06-01",{"date":131,"type":99},"2027-02-28",{"name":5,"class":6},1]