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Modulation of Gut Microbiota to Enhance Health and Immunity

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ClinicalTrials.gov Identifier: NCT04884776
Recruitment Status : Recruiting
First Posted : May 13, 2021
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
Mak Wing Yan, Chinese University of Hong Kong

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Gut Microbiota COVID-19 Vaccine Dietary Supplement: Microbiome immunity formula Dietary Supplement: Active placebo Not Applicable

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 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 484 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Modulation of Gut Microbiota to Enhance Health and Immunity of Vulnerable Individuals During COVID-19 Pandemic
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active arm
Subject will be instructed to take microbiome immunity formula 2 sachets daily for a total of 12 weeks.
 Dietary Supplement: Microbiome immunity formula
Microbiome immunity formula contains probiotics blend (3 Bifidobacteria, 10 billion CFU per sachet)
Placebo Comparator: Placebo arm
Subject will be instructed to take active placebo daily for a total of 12 weeks.
 Dietary Supplement: Active placebo
Active placebo contains active vitamin


Outcome Measures
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Primary Outcome Measures :
  1. Restoration of gut dysbiosis [ Time Frame: 3 months ]
    Proportion of patients achieving restoration of gut dysbiosis at 3 months


Secondary Outcome Measures :
  1. Immunogenicity of the COVID-19 vaccine [ Time Frame: 3 months and 6 months ]
    Measured by serum neutralization assay against pseudo virus and live virus, and IgM and IgG against receptor-binding domain [RBD] and S1

  2. Change in gut microbiome [ Time Frame: 1, 3, 6, 9 and 12 months ]
    Measured the microbial analysis result by real time-PCR and metabolite profiling by liquid chromatography-mass spectrometry

  3. Changes in plasma inflammatory cytokines [ Time Frame: 3 months and 6 months ]
    Measured the inflammatory cytokines (CRP or ESR) in blood result

  4. Adverse events [ Time Frame: 12 months ]
    Adverse events after COVID-19 vaccination

  5. Number of unscheduled hospitalisation and clinic visits [ Time Frame: 1, 3, 6, 9 and 12 months ]
    Number of unscheduled hospitalisation and clinic visits

  6. Changes of quality of life [ Time Frame: 1, 3, 6, 9 and 12 months ]
    Measured the score of EQ-5D-5L which measure the health-related quality of life

  7. Changes in glycaemic control [ Time Frame: 3, 6 and 12 months ]
    Measured by HbA1c


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04884776


Contacts
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Contact: Joyce WY Mak, FHKAM 3505 3307 wingyanmak@cuhk.edu.hk
Contact: Amy Li 26373225 amyli@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital, Shatin Recruiting
Hong Kong, Hong Kong
Contact: Joyce WY Mak, FHKAM    3505 3307    wingyanmak@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Joyce WY Mak, FHKAM Chinese University of Hong Kong
More Information
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Publications:

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Responsible Party: Mak Wing Yan, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04884776    
Other Study ID Numbers: IMPACT Study
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases