High Concentration Probiotic May Reduce Gastrointestinal and Neurological Inflammation in HIV Patients

ROCKVILLE, Md., Oct. 21, 2016 /PRNewswire-USNewswire/ -- A new study published in the International Journal of Molecular Sciences by researchers at the Sapienza University of Rome shows that probiotics may play a role in reducing neurological inflammation, which has been implicated in a number of HIV-associated cognitive disorders, ranging from very mild impairment to severe dementia. This study adds to the growing science around the gut-brain connection, reports ExeGi Pharma.

In patients with HIV, including those who control their disease with antiretroviral drugs (ART), the gut microbiome is very different than the microbiome of those uninfected with HIV. Recent data suggest that this state of "dysbiosis" in HIV patients may lead to a breakdown in the gut's ability to protect the body from immunologic threats, allowing disease causing bacteria and other toxins to cross into the blood stream. This bacterial "invasion" then causes a systemic inflammatory response that can have negative effects throughout the body, including in the central nervous system (CNS), where inflammation is a root cause of a variety of HIV-related neurocognitive dysfunctions. Researchers believe the probiotics (sold as Visbiome^TM in the United States and Vivomixx^TM in Europe) may help normalize the gut microbiome in HIV patients and improve the normal barrier function in the gut.

"This is exciting data because it suggests that it may be possible to address the neurocognitive issues common in the HIV population by altering the gut microbiome with probiotics," said Dr. Vincenzo Vullo, Dean of the Faculty of Medicine and Head of the Department of Infectious Disease at the "La Sapienza" University, Rome, Italy. "We have additional research ongoing in this field, but it is becoming increasingly clear that probiotics and the gut microbiome will have implications in the management of HIV."

Investigators hypothesized that alterations in the gut microbiome of HIV patients could change metabolic pathways involved in the metabolism of the amino acid tryptophan, a necessary component of the human diet which is found in a wide variety of protein based food. Disruptions in tryptophan digestion have been implicated in the production of cytotoxic metabolites, such as quinolinic acid, which may be the source of some neurological inflammation in patients with HIV. To test their hypothesis, researchers analyzed the following:

• First, researchers sought to determine if the tryptophan metabolic pathway could be altered, and if so, whether or not normalization of this metabolic process would result in a reduction in neurological inflammation. HIV-positive patients on ART were administered a high daily dose of the Visbiome probiotic, containing 1800 billion live bacteria for 6 months.
• Then, colonic tissue samples and cerebrospinal fluid were evaluated before and after the initiation of probiotic treatment.
• Both biomarkers (indolamine-2,3-dioxygenase and neopterin) were reduced by statistically significant amounts.

Timothy Ray Brown, also known as "The Berlin Patient," was the first patient ever to receive a functional cure for HIV when he received a bone marrow stem cell transplant from a donor with a rare natural resistance to HIV. Today, Timothy is a leading treatment advocate and co-founder of the Cure for AIDS Coalition. Timothy commented on the recent findings, "The data being presented by this small but critical study of Visbiome is emphasizing how broad the implications of microbiome restoration may prove to be for HIV patients. These results establish a connection between the gut tissue, immune activation and disease progression, and further suggest that it may be possible to effect this with a therapeutic intervention such as this probiotic."

Several studies are currently underway in the U.S., Europe, and Canada to evaluate the potential impact of probiotics in the gastrointestinal functions of HIV patients. To learn more about these trials please visit ClinicalTrials.gov. For information about Visbiome in the United States, please visit www.visbiome.com, for information about Vivomixx in Europe, please visit www.vivomixx.eu.

About Visbiome™
Visbiome™ is a high probiotic consisting of eight strains of live, freeze-dried lactic acid bacteria. The product is a medical food of the dietary management of dysbiosis associated with irritable bowel syndrome (IBS), ulcerative colitis, pouchitis and hepatic encephalopathy. Visbiome is a non-drug therapy that addresses distinct nutritional requirements, to promote microbial balance, in people with IBS, ulcerative colitis, pouches, and hepatic encephalopathy. There are currently eight ongoing studies evaluating Visbiome in several clinical conditions. Patients should consult with a physician before taking Visbiome.

About ExeGi Pharma
ExeGi Pharma, LLC is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. ExeGi's team leverages the growing advances in the field of microbiome science to deliver novel clinically supported live biotherapeutic and probiotic treatments for a wide variety of unmet medical needs.

Contact: Jessica Schultz, [email protected], 202-591-4005

SOURCE ExeGi Pharma

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