Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT05548452
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intestinal Microbiota Transplant (IMT) Capsules — DRUG
    Capsules containing freeze-dried intestinal microbiota from healthy human donors
  • Placebo Capsules — DRUG
    Capsules containing an inactive substance ("sugar pill")

Study Details

The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking.

Key Dates

Start date
Nov 21, 2022
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Dec 30, 2026

Study Design

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

Arms

  • Experimental: Intestinal Microbiota Transplant capsules
    Capsules will be provided twice during the trial
  • Placebo Comparator: Placebo capsules
    Capsules will be provided twice during the trial

Primary Outcome Measure

Number of abstinent days [ Time Frame: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Hunter Holmes McGuire VA Medical CenterRichmondVirginia23249-
Virginia Commonwealth UniversityRichmondVirginia23298-

Find similar trials in Richmond, VA

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Hunter Holmes McGuire VA Medical Center· Richmond, VAVirginia Commonwealth University· Richmond, VA

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