Modulation of Gut Microbiota to Enhance Health and Immunity

December 27, 2022 updated by: Mak Wing Yan, Chinese University of Hong Kong

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

453

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital, Shatin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events/Serious adverse events
Time Frame: within 6 months
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Joyce WY Mak, FHKAM, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

May 31, 2024

Study Completion (Anticipated)

May 31, 2024

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 27, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPACT study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19 Vaccine

Clinical Trials on Microbiome immunity formula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe