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Clinical trialNCT02706717CompletedPhase 2Interventional

Effects of the Probiotic Visbiome Extra Strength on Gut Microbiome & Immune Activation Markers

SponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsEnrollment93HIV-1 Infection
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of the study was to evaluate whether the probiotic Visbiome Extra Strength reduces inflammation in HIV-infected men and women when compared to a placebo (inactive medication like a dummy pill). The study evaluated whether taking Visbiome Extra Strength by mouth for 24 weeks was safe and well-tolerated for HIV-infected persons on antiretroviral therapy (ART). Probiotics are germs such as yeast or bacteria that are found in food and supplements that are used to improve the health of the digestive system. Many people refer to probiotics as "helpful bacteria." These bacteria live in the body and help the body work normally. In some medical conditions, including HIV infection, helpful bacteria are replaced with bacteria that can change the normal intestinal function and increase inflammation. The investigators tested whether giving a probiotic restored normal intestinal function and decreased inflammation.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

25 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico
  • Puerto Rico-Aids Crs (5401)

    San Juan, Puerto Rico

United States
  • 31788 Alabama Crs

    Birmingham, Alabama, United States

  • Ucla Care Center Crs (601)

    Los Angeles, California, United States

  • 701 University of California, San Diego Antiviral Research Center Crs

    San Diego, California, United States

  • 801 University of California, San Francisco Hiv/aids Crs

    San Francisco, California, United States

  • University of Colorado Hospital Crs (6101)

    Aurora, Colorado, United States

  • Northwestern University Crs (2701)

    Chicago, Illinois, United States

  • Rush University Medical Center (2702)

    Chicago, Illinois, United States

  • Johns Hopkins Adult Aids Crs (201)

    Baltimore, Maryland, United States

  • Washington University Crs (2101)

    St Louis, Missouri, United States

  • 31786 New Jersey Medical School Clinical Research Center Crs

    Newark, New Jersey, United States

  • 7803 Weill Cornell Upton Crs

    New York, New York, United States

  • 7804 Weill Cornell Chelsea Crs

    New York, New York, United States

  • Columbia Physicians and Surgeons Crs (30329)

    New York, New York, United States

  • Unc Aids Crs (3201)

    Chapel Hill, North Carolina, United States

  • Greensboro Crs (3203)

    Greensboro, North Carolina, United States

  • University of Cincinnati Crs (2401)

    Cincinnati, Ohio, United States

  • Case Crs (2501)

    Cleveland, Ohio, United States

  • the Ohio State University Aids Crs (2301)

    Columbus, Ohio, United States

  • 6201 Penn Therapeutics Crs

    Philadelphia, Pennsylvania, United States

  • Pittsburgh Crs (1001)

    Pittsburgh, Pennsylvania, United States

  • Vanderbilt Therapeutics Crs (3652)

    Nashville, Tennessee, United States

  • Trinity Health and Wellness Center Crs (31443)

    Dallas, Texas, United States

  • Houston Aids Research Team Crs (31473)

    Houston, Texas, United States

  • University of Washington Aids Crs (1401)

    Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PlaceboVisbiome Extra Strength
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Apr 2016
Primary completion
5 Jun 2017
Completion
28 Aug 2017
Last update posted
6 Jan 2020
Registered enrollment
93
Registry id
NCT02706717

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.