Examining the Oral Microbiome and Immune Response in COVID-19
Role of the Oral Microbiome & Mucosal Immunity in COVID-19 Disease: Diagnostic/Prognostic Utility in South Asian Populations
This study looks at how the mouth's germs and immune responses differ in people with COVID-19 compared to those without it, to see how oral health might affect COVID-19 outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05212766 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the differences in mucosal innate immunity and oral microbiome characteristics between COVID-19 patients and control groups from South Asian and White British populations. Participants will provide stimulated whole mouth fluid and blood samples, which will be analyzed for immune responses to SARS-CoV-2 antigens and microbial DNA. The study includes both symptomatic and asymptomatic COVID-19 patients, as well as uninfected individuals, to understand the role of oral health in COVID-19 outcomes. Clinical examinations and questionnaires will also be utilized to gather comprehensive data on oral health status.
Who should consider this trial
Good fit: Ideal candidates include South Asian and White British individuals aged 18 and over, with either confirmed COVID-19 infection or no history of COVID-19.
Not a fit: Patients with a history of COVID-19 vaccination or those who are not willing to provide longitudinal samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how oral health impacts COVID-19 severity and recovery, potentially leading to improved patient management strategies.
How similar studies have performed: While the specific focus on the oral microbiome in relation to COVID-19 is novel, similar studies have shown that oral health can influence systemic diseases and immune responses.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • South Asian and White British persons and those diagnosed with symptomatic or asymptomatic COVID-19 infection. * Aged 18 or over. Able to understand and consent. * Uninfected subjects: no history of COVID-19; not vaccinated; (negative for anti-SARS-CoV2 nucleoprotein antibodies at lab) * For patient groups: Confirmed COVID-19 positivity, symptoms and symptom onset within the past 21 days; Be recently hospitalised with COVID-19 disease; Have COVID-19 disease proven by PCR testing for SARS-CoV-2 within the last 21 days; COVID disease severity graded as per NIH/WHO. * Recovered groups: Have had COVID-19 disease proven by PCR testing for SARS-CoV-2. COVID disease severity graded as per WHO or NIH equivalent criteria * Those willing to participate on a single occasion but unwilling to participate with longitudinal samples will not be excluded. * Smoking, obesity, diabetes, heart disease, antibiotics or treatment related to COVID is not excluded. Exclusion Criteria: * • Those patients unwilling to participate, those unable to understand sufficiently to give informed consent and those unable to participate due to the severity of COVID-19 disease. Those patients classified as not either South Asian or White British heritage. * Patients with malignancy, pregnancy, long term immune suppression, inability to give informed consent, not willing or able to have oral examination. * Diabetes not excluded but screening for diabetes will be performed: glucose will be assessed in blood/serum sample (150ul). Exclusion criteria summary: * Critically ill participants who cannot give informed consent * Those who are not willing to have an oral examination, or donate blood or saliva samples. * Those who cannot chew / drool to provide a SWMF sample due to severe/critical medical conditions * Participants with known malignancies or who are pregnant * Participants who are on long-term immunosuppressants (e.g. for autoimmune diseases) * Participation in other current research that is designed to, or is expected to alter the immune response. * Inability to communicate, understand or read English.
Where this trial is running
London
- Guy's and St Thomas' NHS Trust / King's College London — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Stephen J Challacombe, PhD — King's College London
- Study coordinator: Stephen J Challacombe, PhD
- Email: stephen.challacombe@kcl.ac.uk
- Phone: 02971887188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.