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Modulation of Gut Microbiota to Enhance Health and Immunity

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ClinicalTrials.gov Identifier: NCT04884776
Recruitment Status : Active, not recruiting
First Posted : May 13, 2021
Last Update Posted : December 29, 2022
Sponsor:
Information provided by (Responsible Party):
Mak Wing Yan, Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE April 29, 2021
First Posted Date  ICMJE May 13, 2021
Last Update Posted Date December 29, 2022
Actual Study Start Date  ICMJE June 1, 2021
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2022)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2021)
Restoration of gut dysbiosis [ Time Frame: 3 months ]
Proportion of patients achieving restoration of gut dysbiosis at 3 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2022)
  • 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
  • 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
  • Changes in plasma inflammatory cytokines [ Time Frame: 3 months and 6 months ]
    Measured the inflammatory cytokines (CRP or ESR) in blood result
  • 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
  • Number of unscheduled hospitalisation and clinic visits [ Time Frame: 1, 3, 6, and 12 months ]
    Number of unscheduled hospitalisation and clinic visits
  • 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
  • Changes in glycaemic control [ Time Frame: 1, 6 and 12 months ]
    Measured by HbA1c
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2021)
  • 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
  • Change in gut microbiome [ Time Frame: 1, 3, 6, 9 and 12 months ]
    Change in gut microbiome
  • Changes in plasma inflammatory cytokines [ Time Frame: 3 months and 6 months ]
    Changes in plasma inflammatory cytokines
  • Adverse events [ Time Frame: 12 months ]
    Adverse events after COVID-19 vaccination
  • Number of unscheduled hospitalisation and clinic visits [ Time Frame: 1, 3, 6, 9 and 12 months ]
    Number of unscheduled hospitalisation and clinic visits
  • 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
  • Changes in glycaemic control [ Time Frame: 3, 6 and 12 months ]
    Measured by HbA1c
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modulation of Gut Microbiota to Enhance Health and Immunity
Official Title  ICMJE Modulation of Gut Microbiota to Enhance Health and Immunity of Vulnerable Individuals During COVID-19 Pandemic
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Gut Microbiota
  • COVID-19 Vaccine
Intervention  ICMJE
  • Dietary Supplement: Microbiome immunity formula
    Microbiome immunity formula contains probiotics blend (3 Bifidobacteria, 10 billion CFU per sachet)
  • Dietary Supplement: Active placebo
    Active placebo contains active vitamin
Study Arms  ICMJE
  • Active Comparator: Active arm
    Subject will be instructed to take microbiome immunity formula 2 sachets daily for a total of 12 weeks.
    Intervention: Dietary Supplement: Microbiome immunity formula
  • Placebo Comparator: Placebo arm
    Subject will be instructed to take active placebo daily for a total of 12 weeks.
    Intervention: Dietary Supplement: Active placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 27, 2022)
453
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2021)
484
Estimated Study Completion Date  ICMJE May 31, 2024
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04884776
Other Study ID Numbers  ICMJE IMPACT Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Mak Wing Yan, Chinese University of Hong Kong
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Chinese University of Hong Kong
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joyce WY Mak, FHKAM Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP