Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT05288790
Phase
PHASE2
Status
Recruiting
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Conditions

  • Alcohol Drinking
  • Cardiovascular Diseases
  • Dysbiosis
  • HIV Infections
  • Microtia

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Probiotic — DIETARY_SUPPLEMENT
    Dietary supplement
  • Placebo — DIETARY_SUPPLEMENT
    Placebo sachet

Study Details

Among people living with HIV, heavy drinking increases the risk of heart disease and death. Studies suggest that alcohol changes the number and kind of bacteria in your gut and these changes increase the risk of heart disease and death. This randomized controlled trial will determine whether a pill containing healthy gut bacteria can increase the number good bacteria in the gut, lower levels of inflammation, and lower the risk of heart disease and death.

Key Dates

Start date
Sep 18, 2023
Status verified
Jun 2025
Primary completion
Aug 28, 2026
Completion
Feb 28, 2027

Study Design

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

Arms

  • Experimental: Study Supplement
    Probiotic
  • Placebo Comparator: Study placebo
    Placebo

Primary Outcome Measure

Firmicutes to Bacteroidetes ratio [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
David Crenshaw, MSW
615-322-7343

Find similar trials in Nashville, TN

By condition
HIV
By specialty
Infectious disease
By research site
Vanderbilt University Medical Center· Nashville, TN

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