A new study looking at the role probiotics may play in increasing CD4 cell count in people with HIV infection is underway at the AIDS Healthcare Foundation (AHF). Today, researchers began a 3-month, double-blind, placebo-controlled clinical trial to demonstrate safety and efficacy of taking capsules with 2 billion cells of a strain of Bacillus coagulans probiotics known as GanedenBC30 to increase critical CD4 cell count, a measure of immune status used to gauge progression of HIV infection.
The Centers for Disease Control and Prevention (CDC) estimate that more than 1.1 million people are living in the United States (U.S.) with HIV infection. Current drug regimens have allowed people with HIV infection to live longer; these drugs, however, can cost thousands of
dollars per month and there is still no cure. Unfortunately, government programs to provide life-sustaining drugs to those who cannot afford them have been crippled by the weak economy, and tens of thousands of people are currently without access. The AHF is able to help some patients, but the size of the economic shortfall dwarfs citizens’ current need.
The AHF trial is believed to be the first-of-its-kind in the United States; while small clinical trials conducted in Africa have shown that probiotic yogurts can dramatically increase CD4 cell count in people (test subjects) with HIV infection. However, the results left important questions unanswered. A successful research result would promise a social and economic tool for both patients and doctors to help in the country’s fight against HIV/AIDS that remains without a cure.
Human immunodeficiency virus (HIV) can lead to acquired immunodeficiency syndrome (AIDS) by damaging the body’s immune system — specifically, white blood cells often referred to as CD4 cells that are crucial to the body helping fight diseases. HIV infection is often marked by a state of chronic inflammatory response triggered by the leakage of Gram-negative bacteria from the intestines into the bloodstream. This state of chronic inflammation is believed to leave CD4 cells more prone to infection and destruction by HIV.
Researchers at the AHF hypothesize that probiotic consumption may reduce leakage of Gram-negative bacteria from the intestine, thereby reducing the resulting inflammatory response and destruction of CD4 cells.
“The best solution we have today is the current range of antiretroviral drugs. Some patients, despite taking these agents regularly, are not able to rebuild their immune system which is partly due to state of chronic inflammation created by disruption of gut ecosystem in HIV disease,” says Dr. Homayoon Khanlou, M.D., Chief of Medicine at AHF and the lead investigator on the new clinical trial. “A positive result will provide a new affordable probiotics alternative to those who don’t achieve adequate immune restoration as well as a bridge for those who do not yet have access to HIV/AIDS drugs,” adds Dr. Khanlou.
Two small clinical trials conducted in Africa demonstrated that HIV infected subjects given probiotic yogurt had increased CD4 cell counts compared to those given placebo. However, the nutritional status of HIV-infected people in Africa is believed to be so poor that even minor changes in diet can lead to an improvement in CD4 cell count. Given the stronger nutritional status of HIV infected people in the U.S., a positive outcome from the clinical trial will be more meaningful to medical experts.
“There are many reasons why the previous trials in Africa haven’t received attention here in the U.S., partly because the subject populations are so different,” says Dr. Justin Sonnenburg, Ph.D., a microbiologist and immunologist at Stanford University School of Medicine. “This new clinical trial testing probiotics’ impact on people living with HIV, if successful, would promote dialogue on this very important topic and definitely open up a great deal of interest among researchers.”
Researchers will enroll 24 subjects into the new clinical trial to take either a probiotic capsule or a placebo daily for 90 days. Several key immune measures, including CD4 cell count, will be taken at the start and end of the trial. The capsules will contain the Bacillus coagulans strain of probiotics, sold widely in the U.S. today as dietary supplements to help alleviate common gastrointestinal complaints and ward off cold and flu viruses. There is an additional hypothesis that the probiotic capsules will help alleviate the gastrointestinal symptoms that often accompany HIV infection, and the clinical trial will measure such changes with a widely used rating scale.
Because probiotics are themselves bacteria, there has long been concern related to their use in people with compromised immunity. Several probiotic strains have been implicated in causing opportunistic infections in people with severe illnesses. But the specific probiotic strain being used in the new clinical trial has gone through rigorous safety and toxicity testing. The Bacillus coagulans GBI-30, PTA-6086 strain of probiotics was found to be safe
for all human consumption by an independent panel of experts assembled to assess its safety. The strain has never been implicated in causing opportunistic infection.
The new clinical trial will be partly funded by Ganeden Biotech, a Cleveland, Ohio-based company that sells the Bacillus coagulans GBI-30, PTA-6086 probiotic strain in its Sustenex dietary supplements and to several food and beverage companies that add it as an ingredient to their products. Company representative Marshall Fong says, “We believe it is important to support the search for a low-cost therapy to help people living with HIV/AIDS, especially those without access to high-priced HIV/AIDS drugs. While our small company-size unfortunately prohibits us from providing more research funding, we do plan to donate probiotics to those Americans in need should the research show positive results.”
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and services to more than 139,000 individuals in 23 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific region and Eastern Europe.