DSM’s probiotic to be trialed in COVID-19 exposed households

03 Jun 2020 --- A DSM probiotic is the latest strain to be investigated in the fight against COVID-19. Duke University Health System’s Institutional Review Board has approved a clinical trial of Lactobacillus rhamnosus GG, which is part of the Culturelle brand from DSM’s i-Health, Inc. The probiotic will be trialed in households exposed to COVID-19, with the researchers anticipating that it may be able 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 coronavirus patients.

“Considering the big trial size of 1000 subjects, we project this to go into 2021 and may conclude in Fall 2021. i-Health is supporting the trial by providing clinical supplies as well as partial financial support. We have also provided consultation on clinical design, dose and microbiome analysis testing,” Seema Mody, Senior Director of Product Development at i-Health, tells NutritionInsight.

Household exposure to SARS-CoV-2 is thought to result in as much as a 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 relationship between microbiome functions and COVID-19 risk and illness.

Set to start later this month, the randomized, double-blind, placebo-controlled clinical trial will be led by Dr. Paul Wischmeyer and Dr. Anthony Sung, with i-Health providing support. “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. This study will provide us with a greater understanding of how to care for the most at-risk populations,” says Dr. Wischmeyer. 

This trial is based on multiple prior 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 percent. These benefits may be mediated by the beneficial effects of probiotics on the immune system.

A potential “huge win”Other research teams have also been investigating the potential connection between gut health and COVID-19. 
From a product perspective, Mody notes that this could be a huge win for the company if it gets favorable results. “This will further support immune benefits associated with selected strains of probiotics and build healthcare professional trust. I can imagine that leading to consumers wanting to take Culturelle everyday, similarly to how vitamins are taken. Additionally, physicians may recommend probiotics to optimize people’s immunity,” she says. 

Mody continues that beyond product benefit, the announcement of collaboration further highlights the company’s commitment to science and how its products are recognized as clinically proven and quality products. “With Duke’s endorsement of potential benefits of probiotics with COVID-19, it will further heighten curiosity in healthcare professionals about probiotics.”

Lactobacillus rhamnosus GG is only commercially available in the US under the Culturelle brand. It was chosen for this study based on evidence from over 200 clinical trials proving the bacterial strain’s health benefits, including immune support. Some findings demonstrate that Lactobacillus rhamnosus GG helps prevent ventilator-associated pneumonia in adult patients and decrease the risk of upper respiratory tract infections in children attending daycare.

“Our mission is finding new ways to enhance the health and wellness of people around the world. 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,” says Jane Wadler, Global Senior Vice President of Marketing at i-Health.

Mody also notes that Dr. Wischmeyer is supporting the company in creating social media content in support of Culturelle. “We are planning to do a video with him on probiotics and immunity and have invited him to an expert panel on immunity and probiotics. Dr. Wischmeyer has a significant social media presence, so I see him serving as a nice influencer for us, and has already mentioned Culturelle in his recent Facebook posts. He endorses the importance of nutrition in disease management, so we could potentially have bigger collaboration with him in future.”

Burgeoning research
Groups including the Wischmeyer laboratory have shown that probiotics, such as Lactobacillus rhamnosus GG, can improve intestinal and lung barrier function and homeostasis, increase regulatory T cells, improve antiviral 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. The disease has been characterized by severe lower respiratory tract illness, and patients may manifest an excessive inflammatory response associated with increased complications and mortality. 

Other research teams have also been investigating the potential connection between gut health and COVID-19. Last month, ADM Biopolis and Hospital de Sagunto launched a clinical trial into the effects of administering a food supplement containing three of ADM’s live probiotic strains on COVID-19 patients. Meanwhile, Biosearch Life has undertaken a clinical trial project for its Hereditum Immunactiv K8 product, with the aim of measuring its effectiveness in reducing the incidence or severity of COVID-19 infection.

At a consumer level, the pandemic is also driving a boom in probiotic products. Wadler notes that since the outbreak, consumption of Culturelle’s products has increased by more than 16 percent over the prior year. Probi’s financial report pegs the global probiotics market for growth as consumer interest in immunity is on the rise. Meanwhile, Chr. Hansen anticipates it will see “both favorable and unfavorable impacts” in the second half of this year as a result of the pandemic. Its US subsidiary recently launched an online platform providing inspirational and educational content on probiotics and the human microbiome.

Edited by Katherine Durrell