Probiotics have been used for a long time by the general population to promote a healthy microbial balance. There have been studies of diseases like irritable bowel syndrome and inflammatory bowel diseases.
Probiotic studies in HIV-infected persons have started to be conducted. The results for one particular formula, Visbiome, is looking very positive, both for the benefits and safety of these probiotics to be used in HIV-positive patients.
Two large studies are currently underway in the United States and Canada to further evaluate the impact of Visbiome in HIV. A multi-center study, being conducted by the NIH funded AIDS Clinical Trials Group (ACTG), is looking to determine if the probiotics can reduce damaging systemic inflammation in HIV patients in comparison to placebo. Results of this study are expected to be available in early 2018.
In ACTG A5350, the probiotic Visbiome made by Exegi Pharma, which is a mix of four strains of Lactobacilli, three strains of Bifidobacteria, and one strain of Streptococcus thermophilus is being assessed in individuals with suppressed viral loads and CD4 counts above 200. The study will determine if Visbiome:
Dr. Turner Overton, Associate Professor of Medicine at The University of Alabama at Birmingham and Co-Chair for this study says, “The formulation in Visbiome has been demonstrated to replete the CD4 cell population in the gut of SIV-infected macaques which were administered the probiotic blend. Furthermore, inflammation in the gut was markedly decreased with the formulation administration. Given these results and human studies demonstrating the benefit of the formulation found in Visbiome to improve bowel symptoms in inflammatory bowel diseases, this probiotic has the potential to positively impact HIV disease outcomes,”
A study published in the International Journal of Molecular Sciences by researchers at the Sapienza University of Rome shows that Visbiome probiotics may play a role in reducing neurological inflammation, which has been implicated in a number of HIV-associated cognitive disorders. The range is from very mild impairment to severe dementia. This study contributes to the ever growing science involving the gut-brain connection.
A separate study of Visbiome are being conducted at two sites in Toronto, Canada. This study is mainly looking to see if immune activation, inflammation and microbial translocation can be positively affected by the probiotic.
The enrollment is for men who are virally suppressed with a CD4 count that is below 350, as well as those who are treatment-naïve and ready to begin antiretroviral therapy. It’s hypothesized that probiotics, in this case Visbiome, may boost the immune function for these individuals.
As with the ACTG study, this study was spurred by recent research on the important role the microbiome plays in HIV disease and the potential that probiotics may have in this process. Rupert Kahn, Primary Investigator and Clinician Scientist at the University Health stated, “We are very excited to work with the HIV community on this trial, since clinical testing of complementary therapies has been identified as a research priority by people living with HIV in Ontario, and the preliminary probiotic work in primate models has been so promising.”