Covid-19 & Microbiome Clinical Research
Though respiratory symptoms of Covid-19 pose the most significant threat, evidence has shown a link between global immunity and overall respiratory health through treatment of the gut microbiome.
What impact has Covid-19 had on clinical research?
Though there has been major disruptions and challenges in clinical trials as a result of Covid-19, there is an opportunity to implement some important changes to the current processes in clinical research.
To provide context, BioCentury carried out a survey with 99 different pharma and biotech companies to understand which areas of clinical research companies are seeking guidance and flexibility. the issues of managing ongoing clinical trials during such disruption has been noted as a key concern. For example, the early stage of a clinical trial and understanding the manner in which regulatory bodies would manage and adapt to the current climate in terms of amendments to protocols and general regulatory flexibility was of most importance to companies. A key aspect of the amendments to protocol is the manner in which clinical visits and monitoring would take place, 35 of the 99 companies surveyed noted ‘remote monitoring’ as a measure taken to avoid trial disruptions.
Why look at the gut when discussing Covid-19?
A study conducted by Kupfer & Burke (2020) which was conducted in the early stages of the pandemic, in the Wuhan province found that 23% of patients in the study that were Covid positive presented only digestive symptoms, and no respiratory symptoms. Furthermore, 33% presented with both digestive and respiratory symptoms and 44% presented only respiratory symptoms.
Can probiotics help improve non-digestive symptoms?
Treating respiratory symptoms of Covid-19 is of higher importance than treating digestive symptoms as they are far more deadly and should be the focus of any treatment. However, evidence has shown that probiotics and digestive treatment can have an effect on global immunity and overall respiratory health. If you would like to hear more on the specific studies showing the positive impact of probiotics, our medical writer Suszie Tyree discusses them in the below webinar.
Can we target the gut to help treat COVID-19?
Suszie Tyree presents an interesting study conducted by (Xu et al., 2020), which showed a decrease in the number of bacteria important for gut health in patients with Covid-19, namely, lactobacillus and Bifidobacterium. The data surrounding Covid-19 is ever evolving, however, research is still quite new, (Meazzi et al., 2019) had similar findings in cats with feline coronavirus, where there was no presence of lactobacilli which is usually present in healthy cats.
Covid & microbiome trials
At the time of the below webinar, there were 23 active clinical trials on the microbiome and Covid (clinicaltrials.gov). Of the 23 active trials, 50% were observational (observing the effects of Covid on the microbiome) and 50% were interventional. More specifically, 55% were investigating the microbiome composition, and also observing the immune response (23%). Of the product types used to treat the virus, 14% were probiotics and 14% were biotherapeutics, and 4% were synbiotics. Of the interventional studies, they were predominantly looking at the immune response and microbiome composition, and seeing how their intervention has an effect.
Common inclusion criteria for Covid/Microbiome trials
All participants in such trials up to this point in time suffered with mild Covid symptoms. In terms of assessment of symptoms, in the early stages of trialling, self-reported symptoms were in place. However, as time went on PCR tests were required to confirm and in most instances, but not all, gastrointestinal symptoms were required to ensure the gut was effected.
How Atlantia has adapted operations during Covid-19
Our medical writer, Suszie Tyree speaks on her experience in the early stages of the pandemic, particularly our Covid-19 risk mitigation plan. The managing of protocol deviations and amendments for studies e.g. virtual visits. There has been a major focus on reassessing our standard operating procedures and study documentation, to ensure the correct measures are taken should a participant or member of staff develop Covid-19. Thankfully, we have had 0 cases of Covid among our participants, and staff throughout the pandemic. Measures such as ‘team specific per study’, which is a system that ensures that each clinical study is conducted with one team, this means that participants are in contact with the same clinic team each time they have a visit. Similarly, we utilize a thermal camera upon entrance to the Atlantia clinical site in both Cork, and Chicago checking temperatures of the team and participants.
Atlantia has experience in inflammatory disease such as IBD, and testing inflammatory biomarkers using a disease activity index. Lastly, Barry will speak on immunity/infection, such as URTI, H. Pylori and antibiotic associated diarrhoea, along with a discussion of the range of measurements which can be utilised, depending on the desired outcome of a study. Visit our clinical expertise areas and our research services to learn more.