Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT

NCT05288790 | Recruiting Phase 2 DMC

• 1 other identifier: P01AA029542
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Firmicutes to Bacteroidetes ratio

  Dysbiosis

  6 months

Secondary Outcomes (4)

• Intestinal permeability

  6, 12 months

• Firmicutes to Bacteroidetes ratio

  12 months

• Microbial Translocation

  6, 12 months

• Inflammation

  6, 12 months

Other Outcomes (2)

• Mortality

  6 and 12 months

• CVD risk

  6 and 12 months

Study Arms (2)

Study Supplement

EXPERIMENTAL

Probiotic

Dietary Supplement: Probiotic

Study placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Dietary supplement

Study Supplement

Placebo DIETARY_SUPPLEMENT

Placebo sachet

Study placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infected

You may not qualify if:

• Not fluent in English

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• University of Louisville: collaborator
• Boston University: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Congenital Microtia; Dysbiosis; Alcohol Drinking; HIV Infections; Cardiovascular Diseases

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drinking Behavior; Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Grace Wallace, BS

CONTACT

615-936-5356; grace.wallace@vumc.org

Emily Smith, MPH

CONTACT

6158757253; emily.k.smith@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: This is a two-arm randomized double blind clinical trial study design.

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 21, 2022
• Study Start: September 18, 2023
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

US (1)