Modulation of Gut Microbiota to Enhance Health and Immunity

Gut Microbiota Clinical Trial

Official title:

Modulation of Gut Microbiota to Enhance Health and Immunity of Vulnerable Individuals During COVID-19 Pandemic

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04884776
• Other study ID #: IMPACT Study
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: December 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 453
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Vaccine
• Gut Microbiota

Intervention

Dietary Supplement:
• Microbiome immunity formula
Microbiome immunity formula contains probiotics blend (3 Bifidobacteria, 10 billion CFU per sachet)
• Active placebo
Active placebo contains active vitamin

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital, Shatin	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	within 6 months
Secondary	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	3 months and 6 months
Secondary	Change in gut microbiome	Measured the gut microbiome changes by metagenomic sequencing and metabolite profiling by targeted and/or untargeted metabolites profiling	1, 3, 6, and 12 months
Secondary	Changes in plasma inflammatory cytokines	Measured the inflammatory cytokines (CRP or ESR) in blood result	3 months and 6 months
Secondary	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	1, 3, 6 and 12 months
Secondary	Number of unscheduled hospitalisation and clinic visits	Number of unscheduled hospitalisation and clinic visits	1, 3, 6, and 12 months
Secondary	Changes of quality of life	Measured the score of EQ-5D-5L which measure the health-related quality of life	1, 3, 6, and 12 months
Secondary	Changes in glycaemic control	Measured by HbA1c	1, 6 and 12 months