U.S. Clinical Trial Shows That Probiotics Like Lactobacillus Rhamnosus GG Can Reduce COVID-19 Symptoms When Taken As A Post-Exposure Prophylaxis

COVID-19-Probiotics: An American randomized clinical trial conducted by researchers from Duke University School of Medicine Durham, North Carolina-USA has shown that daily use of Lactobacillus rhamnosus GG (LGG) probiotic may protect against symptom development in instances when it is used as post-exposure prophylaxis within seven days after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

 
Already various emerging evidence suggests susceptibility to infections, including respiratory tract infections, may be reduced by probiotic interventions; hence probiotics may be a low-risk, widely implementable modality to mitigate risk of COVID-19 disease, particularly in areas with low vaccine availability and/or uptake.

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The objective of the randomized clinical trial was to determine whether daily probiotic Lactobacillus rhamnosus GG (LGG) is effective in preventing development of symptoms of illness within 28 days of COVID-19 exposure.
 
The double-blind randomized, placebo-controlled trial across the United States (PROTECT-EHC) enrolled in 2020-2021. Participants were followed for 60 days.
https://clinicaltrials.gov/ct2/show/NCT04399252
 
The study participants included individuals ≥ 1 year of age with a household contact with a recent (≤ 7 days) diagnosis of COVID-19. 182 participants were enrolled and randomized during the study period.
 
All study participants were randomized to receive daily oral LGG or microcrystalline cellulose placebo for 28 days.
 
The primary outcome was development of symptoms within 28 days of exposure to a COVID-19-infected household contact. Stool was collected to evaluate for changes in microbiome structure.
 
Th study findings showed that participants randomized to LGG were less likely to develop symptoms versus those randomized to placebo (26.4% vs. 42.9%, p=0.02). Further, LGG was associated with a statistically significant reduction in COVID-19 diagnosis (log rank p=0.049) via time-to-event analysis. Overall incidence of COVID-19 diagnosis did not significantly differ between LGG and placebo groups (8.8% vs. 15.4%, p=0.17). LGG was well-tolerated with no increased side effects versus placebo. Placebo recipients were more likely to stop the study product, temporarily or permanently, due to symptoms attributed to the study product (5.5% vs. 0%, p = 0.02).
 
The study findings suggest that LGG is well-tolerated and is associated with prolonged time to development of COVID-19 infection, reduced incidence of symptoms, and changes to gut microbiome structure when used as post-exposure prophylaxis within 7 days after exposure. This preliminary work may inform the approach to prevention of COVID-19, particularly in underdeveloped nations where Lactobacillus probiotics have already been utilized to reduce non-COVID sepsis and infectious-morbidity.
 
This study was limited by its remote format, which necessitated a primary endpoint of self-reported symptoms rather than laboratory-confirmed infection; further laboratory-based studies are needed to further define the efficacy of LGG in preventing COVID-19 infection, especially in larger populations and including comparison of pre-exposure vs. post-exposure prophylaxis.
 
The study findings were published on a preprint server and are currently being peer reviewed. https://www.medrxiv.org/content/10.1101/2022.01.04.21268275v1
 
Alongside a pervasive use of vaccines, additional safe, economically accessible, and rapidly implementable strategies will be pivotal in the battle against the COVID-19 disease caused by SARS-CoV-2 coronavirus.
 
To date, emerging evidence implies that general susceptibility to infectious agents may be diminished by probiotic interventions. More specifically, the use of probiotics may manipulate intestinal microbiota and, in turn, modulate human immune system and its inflammatory responses. https://pubmed.ncbi.nlm.nih.gov/30415160/
 
https://pubmed.ncbi.nlm.nih.gov/27327243/
 
https://pubmed.ncbi.nlm.nih.gov/24780623/
 
Certain recent studies suggest that prophylaxis with bacterial Lactobacillus species can particularly halt the development of upper and lower respiratory tract infections, improve outcomes in cases of ventilator-associated pneumonia, and even reduce sepsis burden in healthy infants.
https://pubmed.ncbi.nlm.nih.gov/28813414/
 
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006895.pub3/full
 
https://pubmed.ncbi.nlm.nih.gov/20522788/
 
https://pubmed.ncbi.nlm.nih.gov/27538711/
 
Mounting evidence showed the role for probiotic therapies in preventing or attenuating respiratory infections, and alongside increasing evidence suggests that gut microbiota affect COVID-19 transmission risk and symptom severity.
https://pubmed.ncbi.nlm.nih.gov/33032673/
 
Hence modulation of the gut microbiome via probiotics is a promising strategy for prophylaxis and mitigation of COVID-19. Since March 2020, several trials have launched investigating the benefits of probiotics in both treatment and prevention of COVID-19.

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Probiotics may be a widely useful and low-risk modality to mitigate the risk of coronavirus disease 2019 (COVID-19) disease, most notably in regions and areas with low vaccine availability or uptake. Among them, LGG is the most promising one, as it showed good results in different clinical trials and in vivo experiments.
 
The COVID-19-Probiotics study team led by Dr Paul E. Wischmeyer and Dr Helen Tang from the Duke University School of Medicine aimed to explore the purported benefits of daily use of LGG in COVID-19-exposed household contacts.
 
The study team conducted a randomized, placebo-controlled, double-blind trial across the US, testing the probiotic LGG as post-COVID-19-exposure prophylaxis.
 
The team enrolled a total of 182 individuals older than one year of age that had household contact with a recent (i.e., less than seven days) diagnosis of COVID-19. These participants were randomized to either receive daily LGG or placebo for the duration of 28 days. Furthermore, their stool was collected in order to evaluate the microbiome.


The research hypothesis was that LGG prophylaxis would actually decrease the incidence of symptoms compatible with COVID-19 within 28 days (primary endpoint), but also the number of confirmed diagnoses of COVID-19 infection.
 
The study team by pursuing the intention-to-treat analysis, found that participants who were taking LGG were less likely to develop symptoms by day 28 in comparison to those that took the placebo. Moreover, participants taking LGG had a substantially prolonged time to symptom onset.
 
Although there was a trend to decreased COVID-19 burden in participants randomized to receive LGG, this finding was not statistically significant. In addition, there were no sex-related differences, while older study participants were more likely to report symptomatic disease.
 
However, microbiome analysis clearly showed how study participants who received LGG had a substantially greater abundance of Lactobacillus rhamnosus in their gut in comparison to those who received only placebo, in conjunction with a significant change in the overall structure of resident gut microorganisms.
 
The study findings suggest that LGG probiotic may confer certain protection against the development of COVID-19 infection, but its value is also in halting symptom development when introduced as post-exposure prophylaxis within seven days after exposure.
 
Dr Paul E. Wischmeyer told Thailand Medical News, “Although limited in sample size, our study suggests that LGG is well-tolerated and is associated with prolonged time to development of COVID-19 infection, reduced symptomatic disease, and changes to gut microbiome structure.”
 
Dr Wischmeyer further added, "Further investigation of LGG probiotic intervention in larger randomized controlled trials is warranted, including comparison of pre-exposure vs. post-exposure prophylaxis with LGG probiotic in high-risk populations. These study findings support the notion that our symbiotic microorganisms, our own gut microflora, can be viewed as indispensable partners in the fight against COVID-19, but also against potentially other pandemic diseases in the future.”
 
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