Modulation of Gut Microbiota to Enhance Health and Immunity
NCT ID: NCT04884776
Last Updated: 2022-12-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
453 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-06-01
Study Completion Date
2024-05-31
Brief Summary
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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.
Detailed Description
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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.
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.
Conditions
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Gut Microbiota
COVID-19 Vaccine
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Study Groups
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Active arm
Subject will be instructed to take microbiome immunity formula 2 sachets daily for a total of 12 weeks.
Group Type
ACTIVE_COMPARATOR
Microbiome immunity formula
Intervention Type
DIETARY_SUPPLEMENT
Microbiome immunity formula contains probiotics blend (3 Bifidobacteria, 10 billion CFU per sachet)
Placebo arm
Subject will be instructed to take active placebo daily for a total of 12 weeks.
Group Type
PLACEBO_COMPARATOR
Active placebo
Intervention Type
DIETARY_SUPPLEMENT
Active placebo contains active vitamin
Interventions
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Microbiome immunity formula
Microbiome immunity formula contains probiotics blend (3 Bifidobacteria, 10 billion CFU per sachet)
Intervention Type
DIETARY_SUPPLEMENT
Active placebo
Active placebo contains active vitamin
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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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
1. Age 65 years and above
2. Written informed consents obtained
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
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 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
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
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
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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Chinese University of Hong Kong
OTHER
Sponsor Role
lead
Responsible Party
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Mak Wing Yan
Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Joyce WY Mak, FHKAM
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Prince of Wales Hospital, Shatin
Hong Kong, , Hong Kong
Site Status
Countries
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Hong Kong
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Other Identifiers
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IMPACT Study
Identifier Type: -
Identifier Source: org_study_id