LGG Supplementation in Patients With AUD and ALD

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT05178069
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • : Placebo for Probiotic — DRUG
    Capsule manufactured without active ingredients.
  • Lactobacillus Rhamnosus GG — DIETARY_SUPPLEMENT
    Probiotic nutritional supplement; Lactobacillus Rhamnosus G

Study Details

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

Key Dates

Start date
Jun 1, 2022
Status verified
Oct 2025
Primary completion
Aug 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Comparator: Placebo for Probiotic
    Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.
  • Active Comparator: Active Comparator: Lactobacillus Rhamnosus GG
    Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.

Primary Outcome Measure

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 [ Time Frame: 180 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Louisville HospitalLouisvilleKentucky40202
Vatsalya Vatsalya, MD, PgD, MSc, MS, FRSM
[email protected]
502-952-8928
Steve Mahanes
[email protected]
5028521388

Find similar trials in Louisville, KY

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
University of Louisville Hospital· Louisville, KY

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