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

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Adriana Andrade, MD, MPH

Principal Investigator

Johns Hopkins University

Edgar T Overton, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.

NOTE: The term "licensed" refers to a US FDA-approved kit.

WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.

Treatment Details

Interventions

• Visbiome Extra Strength (Probiotic)

Participant Groups

Group I: Visbiome Extra Strength Active Control 1 Intervention

Group II: Placebo for Visbiome Extra Strength Placebo Group 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Trinity Health and Wellness Center CRS (31443) Dallas, TX

6201 Penn Therapeutics CRS Philadelphia, PA

31788 Alabama CRS Birmingham, AL

UCLA CARE Center CRS (601) Los Angeles, CA

More Trial Locations

Who Is Running the Clinical Trial?

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Lead Sponsor

Trials

103

Patients Recruited

74,200+

AIDS Clinical Trials Group

Lead Sponsor

Trials

101

Patients Recruited

73,600+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3361

Patients Recruited

5,516,000+

Exegi Pharma, LLC

Industry Sponsor

Trials

3

Patients Recruited

220+

Exegi Pharma, LLC

Collaborator

Trials

2

Patients Recruited

170+