In this study, Visbiome, the high potency, eight strain probiotic formula was assessed in long-term treated HIV-positive patients on ART to see to see what effect in had on the gut barrier function and also to see if it was safe to use in HIV patients.
The study took place at the Sapienza University of Rome, Italy, and published in published in the Journal of Immunity, Inflammation and Disease.
The investigators looked at many clinical and biochemical indicators that showed an improvement in the integrity of the gastrointestinal epithelial cell wall as well as an overall reduction in damaging systemic inflammation.
We know that the gut contains literally trillions of organisms that form a complex bacterial community.
One of the main functions of the digestive system is to separate these bacteria from other internal organs. They do this with the help of a single layer of epithelial cells that form a physical and immunological barrier.
Gut bacteria is prevented from getting in to the bloodstream. If this epithelial barrier is negatively affected, it can lead to circulation of bad bacteria throughout the body.
HIV patient's epithelial barrier is compromised because it's damaged soon after the virus is contracted. Unfortunately, the integrity of the GI tract often remains severely damaged even when HIV is treated with antiretroviral therapy.
Often, this leads to low grade inflammation throughout the body and the immune system is affected. Then there is the concern of development of other HIV-related conditions like bone fractures, diabetes, cardiovascular and kidney disease. (Ref 1, 2)
Visbiome has been shown to help support this barrier function. The probiotics are able to excluding damaging bacteria and also release bioactive compounds like butyrate. Butyrate is a fatty acid that helps control the growth of the cells lining the gut, to make sure there’s good balance between old cells dying and new cells being formed.
Visbiome helps in what they refer to as 'tightening the junctions between the epithelial cells'.
Dr. Giancarlo Ceccarelli M.D., Ph.D., HIV treatment specialist and the clinical researcher who conducted the study, says that it's the first time that a probiotic has been shown to clearly improve the integrity of the gastrointestinal epithelial cell wall in HIV patients.
He says that it looks like there are multiple therapeutic mechanisms at work, but that the improvement in Th17 immune cells in the GI tissue was of particular interest. He continues to say that in the HIV population, a depletion of Th17 in the gastrointestinal tract is common and that it is a significant driver of the loss of intestinal barrier function.
They also noted that there were no adverse safety-related findings associated with the use of Visbiome in this subject group.
The researchers advised against broadly translating this research to apply to any other probiotic formulas, as these clinical findings were specific to using the particular strains of the Visbiome probiotic formula dealing with an immunocompromised population.
The good news is that there are 2 more large studies currently underway in the USA and Canada to continue to evaluate how Visbiome affects the HIV population.
Presently, there is a multi-center study that is being conducted by the NIH funded AIDS Clinical Trials Group (ACTG), to see whether Visbione can reduce damaging systemic inflammation in HIV patients in comparison to placebo.
The outcomes of this study are expected to be released in early 2018.
This is a high potency probiotic medical food that contains 8 strains of live, freeze-dried lactic acid bacteria.
Visbiome is especially formulated for the dietary management of dysbiosis associated with IBS, ulcerative colitis, pouchitis, and hepatic encephalopathy.
Visbiome is a non-drug therapy that looks at distinct nutritional requirements that are necessary to promote microbial balance in those with IBS, ulcerative colitis, pouchitis, and hepatic encephalopathy that can't be addressed by change of diet alone.
Visbiome currently has eight clinical trials, as a medical food, used in a variety of new disease states including HIV, autism spectrum disorders, and liver cirrhosis.
1 Guaraldi G, Orlando G, Zona S, et al. Premature age-related comorbidities among HIV-infected persons compared with the general population. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2011; 53(11):1120–1126.
2 Marchetti G, Tincati C, Silvestri G. Microbial translocation in the pathogenesis of HIV infection and AIDS. Clinical Microbiology Reviews. 2013; 26(1):2–18.
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