CROMWELL, Conn., June 2, 2020 /PRNewswire/ -- Duke University Health System's Institutional Review Board approved a randomized, double blind, placebo-controlled clinical trial of the probiotic Lactobacillus rhamnosus GG in COVID-19 exposed households. Led by Drs. Paul Wischmeyer and Anthony Sung, the researchers anticipate that probiotics show promise to 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. Household exposure to SARS-CoV-2 is thought to result in up to >20-fold increased risk of infection. This initial trial will provide an expanded understanding of the epidemiology of COVID-19 in household contacts and the role of the microbiome in COVID-19 risk and illness. The trial will specifically study and utilize the commercial probiotic, Culturelle®, delivering Lactobacillus rhamnosus GG, in household contacts at high risk for COVID-19.
The clinical trial, planned to start later this month, is based on multiple randomized clinical trials and meta-analyses that have shown that prophylaxis with probiotics, working through the gastrointestinal microbiota, may reduce upper and lower respiratory tract infections, sepsis, and ventilator-associated pneumonia by 30-50%. These benefits may be mediated by the beneficial effects of probiotics on the immune system. The Wischmeyer laboratory and others have shown that probiotics, such as Lactobacillus rhamnosus GG, can 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.
These clinical and immunomodulatory benefits are especially relevant to individuals who have developed or are at risk of developing COVID-19. COVID-19 has been characterized by severe lower respiratory tract illness, and patients may manifest an excessive inflammatory response associated with increased complications and mortality. "We hypothesize that Lactobacillus 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."
Lactobacillus rhamnosus GG was selected for inclusion in the study based on evidence from over 200 clinical trials proving the bacterial strain's health benefits, including immune support, with select findings demonstrating the probiotic's help in preventing ventilator-associated pneumonia in adult patients and decreasing the risk of upper respiratory tract infections in children attending day care. Culturelle® is the only commercially available brand in the U.S. with 100% Lactobacillus rhamnosus GG products, and i-Health, Inc., marketer of 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."
About Culturelle® Probiotics
Culturelle® is a leading probiotic brand focused on supporting the digestive and immune health of families worldwide†. Its portfolio of products covers the needs of families from infants to adults. Using only ingredients that pass the highest standards of testing, Culturelle® products contain probiotic strains that have been thoroughly researched, such as Lactobacillus rhamnosus GG, which has over 30 years of scientific research and over 200 clinical studies.
†Based on: Nicholas Hall & Company, DB6 Global OTC Database. Value Share, Calendar 2019.
Culturelle® is a trademark of DSM. Culturelle® is distributed by i-Health, Inc.
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