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LGG Supplementation in Patients With AUD and ALD

Study acronym: AUD+ALD
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 31, 2025 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Sep 24, 2025, no change to tracked fieldsv19-v20
  2. Eligibility criteria revisedv18
  3. Study Identification, Study Status, Study Design, Contacts/Locations, IPDSharingv17
  4. 2 versions Re-verified since May 11, 2023, no change to tracked fieldsv15-v16
  5. Start date: Mar 2, 2023 to Jun 1, 2022v14
Show 12 earlier versionsHide 12 earlier versions
  1. Primary completion date: Nov 30, 2025 to Aug 31, 2026
    • Study completion date: Mar 1, 2026 to Feb 28, 2027
    v13
  2. Start date: Jan 2, 2023 to Mar 2, 2023v12
  3. Start date: Oct 2022 to Jan 2, 2023v11
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v10
  5. Start date: Oct 1, 2022 to Oct 2022v9
  6. Start date: Aug 1, 2022 to Oct 1, 2022v8
  7. 2 versions Re-verified since Jul 10, 2022, no change to tracked fieldsv6-v7
  8. Start date: Jun 1, 2022 to Aug 1, 2022v5
  9. Start date: Apr 1, 2022 to Jun 1, 2022v4
  10. Start date: Feb 1, 2022 to Apr 1, 2022v3
  11. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05178069
Lead Sponsor University of Louisville
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
(from sponsor)		 Alcohol Use Disorder, Alcohol-associated Liver Disease
Related terms Alcoholism
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov