A5350: Effects of Visbiome Extra Strength on Gut Microbiome and Immune Activation Markers

Safety, Tolerability and Effects of the Probiotic Visbiome Extra Strength on Gut Microbiome and Immune Activation Markers in HIV-infected Participants on Suppressive Antiretroviral Therapy: A Phase II Study

Study Description
Many factors contribute to the development of aging-related conditions, including gastrointestinal (GI) diseases, such as persistent inflammation (irritation) and changes in the gut microbiome (microbial make-up). Researchers are studying the harmful effects of persistent inflammation and microbial changes in order to find ways to prevent these complications in HIV-infected participants. A5350 is a randomized, double-blind, two-arm pilot study of probiotic Visbiome Extra Strength therapy for 24 weeks. Visbiome Extra Strength is a probiotic with potential therapeutic effects on GI diseases. 

A substudy, A5352s, will be conducted in a subset of participants to collect colon biopsies via flexible sigmoidoscopy.   

Why is this study being done?
The purpose of the study is to learn more about the effects of Visbiome Extra Strength on GI damage in people who have HIV infection and to determine its safety and tolerability. We want to learn if treatment with Visbiome Extra Strength will decrease inflammation, improve gut health, and maintain these improvements after treatment.

The substudy will evaluate inflammation in the colon.  

Who can join?
Participants in the study must:

  • Have HIV infection
  • Be on stable HIV treatment for at least the last 24 weeks
  • Have undetectable (<50 copies) HIV viral load for at least 48 weeks
  • Have a CD4 count ≥200
  • Not have chronic hepatitis B or hepatitis C

What do I need to do in the study?
Participants will be assigned by chance to either:

  • Treatment Group: Visbiome Extra Strength + stable antiretroviral therapy (ART) for 24 weeks
  • Control Group: Placebo for Visbiome Extra Strength + stable ART for 24 weeks

Participants will be followed off probiotic therapy/placebo for an additional 12 weeks (38 weeks total).

What treatments or drugs are involved with this study?
Visbiome Extra Strength or placebo will be supplied by the study. HIV treatment will not be provided. 


Study Status: 

Participating ACTG Sites