LOS ANGELES A new study looking at the role probiotics may play in increasing CD4 cell count in people with HIV is under way at the AIDS Healthcare Foundation, the foundation announced Tuesday.
Researchers at the AHF hypothesized 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,” stated Homayoon Khanlou, lead researcher. “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," Khanlou said. "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," Khanlou added.
Researchers have initiated 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 AHF trial is believed to be the first-of-its-kind in the United States, the Foundation stated, though small clinical trials conducted in Africa have shown that probiotic yogurts can dramatically increase CD4 cell count in people (test subjects) with HIV infection.
"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," noted Justin Sonnenburg, 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.
The new clinical trial will be partly funded by Ganeden Biotech, a Cleveland-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.