Researchers from Duke University will be exploring the role of the microbiome in COVID-19 risk and illness. The randomized, double blind, placebo-controlled clinical trial, approved by Duke University Health System's Institutional Review Board, will be led by Drs.Paul Wischmeyer and Anthony Sung and will focus on Lactobacillus rhamnosus GG in COVID-19 exposed households. The trial, which is planned to begin later this month, will use Culturelle fromDSM's i-Health, Inc., according to a press release.

The release notes that household exposure to SARS-CoV-2 is thought to result in up to >20-fold increased risk of infection. For household contacts and caregivers of known COVID-19 patients, the company says, the researchers anticipate that probiotics show promise to:
    • Reduce the risk of SARS-CoV-2 infection
    • Reduce the severity of COVID-19 disease
    • Reduce symptoms
The release  notes that the Wischmeyer laboratory and others previously have shown that probiotics, such asLactobacillus rhamnosusGG, 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--benefits that are especially relevant to those who have developed or are at risk of developing COVID-19. "We hypothesize thatLactobacillus rhamnosusGG will directly influence the microbiota, which may in turn reduce COVID-19 infection risk and severity of disease and symptoms," Dr. Wischmeyer said in the release. "This study will provide us with greater understanding of how to care for the most at-risk populations."

Lactobacillus rhamnosusGG was specifically selected to be included in the study based on evidence from over 200 clinical trials that have proven its health benefits, including immune support, according to the release, which specifies that select findings have demonstrated the strain's help in preventing ventilator-associated pneumonia in adult patients and decreasing risk of upper respiratory tract infections in children attending day care.
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"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."