Modulation of Gut Microbiota to Enhance Health and Immunity

Chinese University of Hong Kong453 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

453

Conditions

Gut Microbiota COVID-19 Vaccine

Interventions

Microbiome immunity formulaDIETARY_SUPPLEMENT

Microbiome immunity formula contains probiotics blend (3 Bifidobacteria, 10 billion CFU per sachet)

Active placeboDIETARY_SUPPLEMENT

Active placebo contains active vitamin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Prince of Wales Hospital, Shatin

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

Adverse events/Serious adverse events

Proportion of patients who presented with new symptoms/diseases which exerted unfavourable impacts on subjects. Serious adverse events are those adverse clinical events that resulted in hospital admission and/or death

Time frame: within 6 months

Secondary Outcomes

Immunogenicity of the COVID-19 vaccine

Measured by serum neutralization assay against pseudo virus and live virus, and IgM and IgG against receptor-binding domain \[RBD\] and S1

Time frame: 3 months and 6 months

Change in gut microbiome

Measured the gut microbiome changes by metagenomic sequencing and metabolite profiling by targeted and/or untargeted metabolites profiling

Time frame: 1, 3, 6, and 12 months

Changes in plasma inflammatory cytokines

Measured the inflammatory cytokines (CRP or ESR) in blood result

Time frame: 3 months and 6 months

Restoration of gut dysbiosis

It is defined as improvement in (i) gut microbiome composition and diversity; (ii) functional potential (i.e., MetaCyc pathway abundances); and (iii) proliferation of beneficial bacteria genus (i.e., bifidobacteria, eubacterium, roseburia and other short-chain fatty acids producers

Time frame: 1, 3, 6 and 12 months

Number of unscheduled hospitalisation and clinic visits

Time frame: 1, 3, 6, and 12 months

Changes of quality of life

Data from ClinicalTrials.gov

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