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

Study Location:

Topic:

Clinicaltrials.gov Link:

https://clinicaltrials.gov/ct2/show/NCT02706717?term=A5350&rank=1

Coordinator:

​Ilene Wiggins, RN 

Enrollment:

Closed

Trial Period:

Ongoing

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 patients. 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.  

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

​Ilene Wiggins, RN 
410-614-2766
iwiggin1@jhmi.edu 

Categories

Location
Topic

Clinical Trials

A5290, A Randomized, Phase 2b Study of a Double-Dose...

Rifampin (RIF), the cornerstone of TB treatment, has very problematic drug-drug interactions with PIs. The use of relatively...

Read More

A5128: Consent for Use of Stored Patient Specimens for...

The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood and other...

Read More

P1108: A Phase I/II, Open-Label, Single Arm Study to...

This purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of bedaquiline (BDQ) in...

Read More

A5273: Multicenter Study of Options for Second-Line...

The study is being done with people who are taking their first anti-HIV drug regimen (including an Non-Nucleoside Reverse...

Read More

P2010: Phase III Study of the Virologic Efficacy and Safety...

IMPAACT 2010 is a Phase III, three-arm, randomized, open-label study of HIV-1-infected pregnant women initiating either a...

Read More