PROTECT-EHC is a new clinical trial testing the effects of a well-known probiotic on the COVID-19 transmission within the same household.
COVID-19 (or SARS-CoV-2) continues to mutate and spread around the world. Our lives are on hold, waiting to stop its spread and limit its impact on our health. The damage caused has been and remains dramatic, both in terms of human loss, associated diseases and financial costs. Strategies to mitigate the contamination and severity of COVID-19 infection are essential.
One strategy considered: probiotics
One strategy is to act on the composition of the intestinal microbiota via probiotic supplementation. Currently, 16 studies are looking to show the benefits of probiotics on COVID-19, such as the PROVID-19 study.
As explained in this article, probiotics can provide many benefits for our well-being and health.
Indeed, they are notably capable of modulating the immune system and inflammation while improving infections, whether gastrointestinal or respiratory.
This is the case of Lactobacillus rhamnosus GG, the most studied probiotic in the world. Numerous in vivo and clinical trials attest to its success in these different aspects. This is why the PROTECT-EHC research team decided to select it as a test probiotic.
However, can this probiotic affect the risk of COVID-19 transmission?
PROTECT-EHC: the course of the study
The researchers chose to test L. rhamnosus GG on individuals over the age of one, who had a household member infected with the virus.
The population selected was not chosen at random. Indeed, the risk of contamination within a single household is between 10 and 20% according to some studies (Burke et al., 2020 ; Boulware et al., 2020 ; Madewell et al., 2020).
Thus, the people selected will be randomised and divided into 2 groups, without knowing the product they will consume. They should ingest over 28 days:
- Either two capsules containing a total of 20 billion CFU of L. rhamnosus GG for those over 5 years of age or one capsule of 10 billion CFU for those under 5 years of age;
- Or one placebo capsule.
In the course of the study, they will be asked to complete various questionnaires to provide information on:
- their demographic data,
- their medical history,
- details of the infection of the infected patient in their household,
- their exposure to the virus,
- the symptomatology,
- adverse events related to the product and COVID-19.
In parallel, the volunteers will be asked to collect faecal and nasal samples themselves at different times: on day 0 (before any supplementation is started), on day 7 and on day 28 (last day of supplementation).
The nasal samples will help to determine whether the participant has been infected with the virus, while the faecal samples will provide information about the microbiota.
All of these data will allow researchers to evaluate :
- the impact of rhamnosus GG on the microbiota of people infected with COVID-19;
- the impact of rhamnosus GG on people in contact with people infected with the virus;
- the symptomatology;
- clinical complications;
- differences in baseline microbiota predicting risk of COVID-19 infection (i.e. the protective microbiota signature);
- changes in microbiota due to virus infection.
Important results for the management of infectious diseases
The information gathered in this trial will be very useful for the future. They will help to better understand the relationship between the microbiome and COVID-19 and to identify relevant microbiological targets to mitigate the spread of the virus.
The results of this clinical trial may enable a new management of COVID-19 with a safe, inexpensive, readily available and rapidly deployable probiotic solution.
They will also consolidate scientific knowledge on infectious diseases.
At present, the recruitment of volunteers is closed. The results of this study are still awaited. We’ll keep you posted on progress, so stay tuned!
LC
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Picture: Freepik
