modulation of gut microbiota to enhance health and immunity

Conditions: Gut Microbiota; COVID-19 Vaccine

Summary: the novel coronavirus infection (covid-19) caused by the sars-cov-2 virus is now a pandemic and has culminated major morbidity and mortality globally. studies have shown that patients with underlying type 2 diabetes mellitus (dm), obesity, old age and hypertension had a higher risk of developing severe covid-19 infection and mortality related to covid-19.emerging evidence has shown that gut microbiota plays an important role in the pathogenesis of covid-19.

hypothesis we hypothesize that modulating the gut microbiota with a microbiome immunity formula can rebalance the gut microbiota in populations at risk of infection, like, patients with type 2 dm and elderlies and can lower the number of hospitalisation and reduce side effects associated with covid-19 vaccination. aim we aim to evaluate the efficacy of modulating gut microbiota with a microbiome immunity formula in vulnerable subjects (patients with underlying type 2 dm and elderlies) in improving immune functions, reducing adverse events associated with covid-19 vaccinations and reducing hospitalisation in susceptible individuals during the covid-19 pandemic. study design this is a double-blinded, randomized, active-placebo controlled study comparing a microbiome immunity formula and placebo in enhancing immunity and reducing hospitalisation within one year. except two kinds of subjects (substudy 1: patients with type 2 dm and substudy 2: elderly individual) will be included in respective substudy, all other methodologies are the same. in each substudy, at least half of the recruited subjects will plan to receive covid-19 vaccination and start to take the study products after vaccination. recruited subjects will be randomised to receive a microbiome immunity formula or active placebo for 3 months, with another 9 months follow-up after completion of study products.

Eligibility criteria:
substudy 1 inclusion criteria: 1. age 18 years - below 65 years 2. a confirmed diagnosis of type 2 dm for ≥ 3 months with stable control (i.e. no change in dm medications in recent 2 months) 3. written informed consents obtained exclusion criteria: 1. known history of confirmed covid-19 infection 2. known active sepsis or active malignancy 3. known increased infection risk due to underlying immunosuppressed state which includes: * prior organ or hematopoietic stem cell transplant * neutropenia with absolute neutrophil count (anc) \<500 cells/ul at the time of study inclusion * known hiv infection with cd4 \<200 cells/ul at the time of study inclusion * on concomitant immunosuppressants or corticosteroid at a dose of prednisolone equivalent dose 10mg or more for more than 3 months 4. known history or active infective endocarditis 5. on peritoneal dialysis or haemodialysis 6. documented pregnancy substudy 2 inclusion criteria: 1. age 65 years and above 2. written informed consents obtained exclusion criteria: 1. known history of confirmed covid-19 infection 2. known active sepsis or active malignancy 3. known increased infection risk due to underlying immunosuppressed state which includes: * prior organ or hematopoietic stem cell transplant * neutropenia with absolute neutrophil count (anc) \<500 cells/ul at the time of study inclusion * known hiv infection with cd4 \<200 cells/ul at the time of study inclusion * on concomitant immunosuppressants, chemotherapies or corticosteroid at a dose of prednisolone equivalent dose 10mg or more for more than 3 months 4. known history or active infective endocarditis 5. on peritoneal dialysis or haemodialysis 6. known active malignancy 7. known terminal illness with life expectancy less than 3 months