The study will use the commercial Culturelle probiotic brand, which is formulated with LGG. Led by Drs. Paul Wischmeyer and Anthony Sung, the researchers plan to recruit over 1,000 people to participate in their study, which will investigate if probiotics may directly reduce the risk of SARS-CoV-2 infection and severity of COVID-19 disease and symptoms in household contacts and caregivers of known COVID-19 patients.
Duke University Health System's Institutional Review Board recently granted approval for the trial and details can be found on clinicaltrials.gov. The clinical trial is planned to start later this month.
Household exposure to SARS-CoV-2 is reported to increase the risk of infection by 20-fold or more. Based on multiple randomized clinical trials and meta-analyses that have shown that prophylaxis with probiotics, working via the gastrointestinal microbiota, may reduce upper and lower respiratory tract infections, sepsis, and ventilator-associated pneumonia by 30-50%.
The Wischmeyer lab and others have previously reported that probiotics, such as LGG, may improve intestinal and lung barrier function and homeostasis, increase regulatory T cells, improve anti-viral defenses, and decrease pro-inflammatory cytokines in respiratory and systemic infections.
“We hypothesize that L. rhamnosus GG will directly influence the microbiota which may in turn reduce COVID-19 infection risk and severity of disease and symptoms,” said Wischmeyer. “This study will provide us with greater understanding of how to care for the most at-risk populations.”
i-Health, Inc., the DSM subsidiary that markets Culturelle, will be providing support for the trial.
“Our mission is finding new ways to enhance the health and wellness of people around the world,” says Jane Wadler, Global SVP of Marketing at i-Health, Inc.
“And with the current public health threat, that mission is intensified. We wholeheartedly applaud and support Dr. Wischmeyer's and Dr. Sung's efforts to better protect those most vulnerable to the risk of COVID-19 and investigate Lactobacillus rhamnosus GG as a potential solution. We are happy to provide clinical supplies for the trial as well as needed financial support to get it off the ground.”
Consultant: “LGG certainly has solid clinical support”
LGG was selected for inclusion in the study based on evidence from over 200 clinical trials proving the bacterial strain's health benefits, said Duke in a press release.
Commenting independently on the prospective study, Mark Miller, PhD, MBA, Principal at Kaiviti Consulting, told NutraIngredients-USA: “With the current SARS-CoV-2 pandemic there is a keen interest in optimizing our immune defenses. LGG certainly has solid clinical support to reduce the downtime associated with viral infections.”
Dr Miller added that a potential complication for this study is the huge variations in responses to the novel coronavirus and the high number of false negative results in testing.
“The sample size is ambitious at greater than 1,000 for 28 days and we will see if this enough to obtain clarity if the primary outcome is prevention of infection, or even duration of symptoms for there is much we do not know about COVID-19.”
The study is estimated to be completed by May 2022, according to clinicaltrials.gov.
* Due to the taxonomic changes to the genus Lactobacillus, Lactobacillus rhamnosus was recently reclassified as Lacticaseibacillus rhamnosus