drugset / Trial / NCT02706717

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

NCT02706717 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2016-04
Primary completion
2017-06-05
Completion
2017-08-28

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Visbiome Extra Strength Other / unclassified — Oral