Status:
UNKNOWN
Modulation of Gut Microbiota to Enhance Health and Immunity
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Gut Microbiota
COVID-19 Vaccine
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Substudy 1
- Age 18 years - below 65 years
- A confirmed diagnosis of type 2 DM for ≥ 3 months with stable control (i.e. no change in DM medications in recent 2 months)
- Written informed consents obtained
Exclusion
- Known history of confirmed COVID-19 infection
- Known active sepsis or active malignancy
- 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
- Known history or active infective endocarditis
- On peritoneal dialysis or haemodialysis
- Documented pregnancy
- Substudy 2
- Inclusion Criteria:
- Age 65 years and above
- Written informed consents obtained
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
453 Patients enrolled
Trial Details
Trial ID
NCT04884776
Start Date
June 1 2021
End Date
May 31 2024
Last Update
December 29 2022
Active Locations (1)
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1
Prince of Wales Hospital, Shatin
Hong Kong, Hong Kong