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NCT05178069 · ClinicalTrials.gov registry record · Phase 2

LGG Supplementation in Patients With AUD and ALD

A Phase 2 study of Alcohol Use Disorder and Alcohol-associated Liver Disease, sponsored by University of Louisville.

Recruiting
Registry status
Phase 2
Development phase
60
Enrollment target
1
Study location

NCT05178069: Recruiting Phase 2 study of Alcohol Use Disorder and Alcohol-associated Liver Disease, sponsored by University of Louisville.

NCT05178069 is a Phase 2 study of Alcohol Use Disorder and Alcohol-associated Liver Disease that is actively recruiting participants, run by University of Louisville. The registered enrollment target is 60 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05178069, a Phase 2 study of Alcohol Use Disorder and Alcohol-associated Liver Disease, is actively recruiting participants, sponsored by University of Louisville.

RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
1
Study location

Study 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 moderate AH

Primary Outcome

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

Conditions Studied

Alcohol Use Disorder Alcohol-associated Liver Disease

Interventions

  • DRUG : Placebo for Probiotic
  • DIETARY_SUPPLEMENT Lactobacillus Rhamnosus GG

Study Locations (1)

Kentucky

  • University of Louisville Hospital - Louisville

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2022-06-01
Est. Completion 2027-02-28
Phase Phase 2
University of Louisville

217 total trials

What NCT05178069 shows while recruiting

NCT05178069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (82% lower).

The record links to 2 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which : Placebo for Probiotic is the first listed.

NCT05178069 reports a single indexed study location in Kentucky.

Frequently Asked Questions

What is clinical trial NCT05178069 about?

NCT05178069 is a clinical study titled "LGG Supplementation in Patients With AUD and ALD". 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 pa...

What is the current status of trial NCT05178069?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2022-06-01. Estimated completion is 2027-02-28.

What conditions does trial NCT05178069 study?

This clinical trial studies the following conditions: Alcohol Use Disorder, Alcohol-associated Liver Disease.

What interventions are being tested in trial NCT05178069?

The interventions under investigation include: : Placebo for Probiotic (DRUG), Lactobacillus Rhamnosus GG (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT05178069?

This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05178069 being conducted?

This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Alcohol Use Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05178069's enrollment target sits among peer trials

60 113th of 184 higher than 65 of 184 other Alcohol Use Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05178069

Source: ClinicalTrials.gov NCT05178069, the US trial registry maintained by the National Library of Medicine. NCT05178069 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.