RECRUITING
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Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT
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
🗓️ Study Start (Actual) 18 September 2023
🗓️ Primary Completion (Estimated) 28 February 2026
✅ Study Completion (Estimated) 31 August 2026
👥 Enrollment (Estimated) 250
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Nashville, Tennessee, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * HIV infected

    Exclusion Criteria:

    • * Not fluent in English
Ages Eligible for Study: 18 Years to 89 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 February 2022
  • First Submitted that Met QC Criteria 10 March 2022
  • First Posted 21 March 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 June 2024
  • Last Update Posted 1 July 2024
  • Last Verified June 2024
I'm interested ...!!