ExeGi Pharma, a biotechnology company focused on the development and commercialisation of live biotherapeutic and probiotic medicines, has announced participation in a clinical trial funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to study probiotic Visbiome in people living with HIV.

Conducted by the NIH-funded AIDS Clinical Trials Group (ACTG), the study will evaluate the safety, tolerability and effect of probiotics on the gut microbiome and immune activation markers in people living with HIV who are currently on suppressive antiretroviral therapy (ART). In early stages of HIV infection, both the immune function of the gastrointestinal tract and its microbiome are altered and fail to normalise, even when patients are treated with ART over many years.

In this study, researchers will examine whether alterations to the intestinal microbial environment can affect key markers of disease progression. Visbiome is the generic formulation VSL#3 which has been shown effective in the dietary management of patients with ulcerative colitis, irritable bowel syndrome (IBS) and pouchitis.

The study is a 9-month-long, prospective, randomized, placebo-controlled clinical trial. ACTG sites throughout the United States will recruit study participants. The ACTG network is one of the largest international cooperative groups focused on HIV research, with over 59 research sites around the world. The ACTG, established in 1987, has played a key role in the development and optimisation of treatment for HIV infection.

“We are pleased to support this research effort by the NIH/NIAID and the ACTG. The probiotic formulation that makes up Visbiome has been extensively studied in numerous gastrointestinal disorders, and this investigation of its potential impact for people living with HIV reflects our growing scientific understanding of the relationship between the gut microbiome and human health,” said Marc Tewey, chief executive officer of ExeGi.

“This study builds on previous research in which the immune defects of HIV are related to effects of the virus on the lymphoid tissue in the gastrointestinal tract and the subsequent alterations in the intestinal microbiome,” said Adriana Andrade MD, MPH, FACP, associate professor of medicine at Johns Hopkins Hospital.

“The results of this study will provide novel insights about the potential for probiotics to improve immune function and decrease intestinal and systemic inflammation, important drivers for disease in people living with HIV,” added fellow investigator, Edgar Turner Overton MD, associate professor of medicine at the University of Alabama at Birmingham.

The AIDS Clinical Trials Group is an international collaboration of clinical investigators with the mission of conducting translational research and therapeutic clinical trials to evaluate novel therapeutic agents and the most effective approaches to treat HIV-1 infection.