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History of Changes for Study: NCT04884776
Modulation of Gut Microbiota to Enhance Health and Immunity
Latest version (submitted December 27, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 7, 2021 None (earliest Version on record)
2 July 27, 2021 Recruitment Status, Study Status, Contacts/Locations and Outcome Measures
3 August 2, 2021 Study Status
4 December 27, 2022 Recruitment Status, Outcome Measures, Study Status, Contacts/Locations and Study Design
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Changes (Merged) for Study: NCT04884776
May 7, 2021 (v1) -- December 27, 2022 (v4)

Changes in: Study Status, Study Design, Outcome Measures and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: IMPACT Study
Brief Title: Modulation of Gut Microbiota to Enhance Health and Immunity
Official Title: Modulation of Gut Microbiota to Enhance Health and Immunity of Vulnerable Individuals During COVID-19 Pandemic
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2021 December 2022
Overall Status: Not yet recruiting Active, not recruiting
Study Start: May 10 June 1, 2021
Primary Completion: April 26 May 31, 2024 [Anticipated]
Study Completion: April 26 May 31, 2024 [Anticipated]
First Submitted: April 29, 2021
First Submitted that
Met QC Criteria:
May 7, 2021
First Posted: May 13, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
May 7, 2021 December 27, 2022
Last Update Posted: May 13 December 29, 2021 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Chinese University of Hong Kong
Responsible Party: Principal Investigator
Investigator: Mak Wing Yan
Official Title: Assistant Professor
Affiliation: Chinese University of Hong Kong
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Gut Microbiota
COVID-19 Vaccine
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Outcomes Assessor)
Allocation: Randomized
Enrollment: 484 [Anticipated] 453 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Restoration of gut dysbiosis Adverse events/Serious adverse events
[ Time Frame: 3 within 6 months ]

Proportion of patients achieving restoration of gut dysbiosis at 3 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
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 ]

Change in gut microbiome Measured the gut microbiome changes by metagenomic sequencing and metabolite profiling by targeted and/or untargeted metabolites profiling
3. Changes in plasma inflammatory cytokines
[ Time Frame: 3 months and 6 months ]

Changes in plasma inflammatory cytokines Measured the inflammatory cytokines (CRP or ESR) in blood result
4. 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
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 1, 6 and 12 months ]

Measured by HbA1c
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Joyce WY Mak, FHKAM
Telephone: 3505 3307
Email: wingyanmak@cuhk.edu.hk
Central Contact Backup: Amy Li
Telephone: 26373225
Email: amyli@cuhk.edu.hk
Study Officials: Joyce WY Mak, FHKAM
Principal Investigator
Chinese University of Hong Kong
Locations: Hong Kong
Prince of Wales Hospital, Shatin
Hong Kong, Hong Kong
Contact:Contact: Joyce WY Mak, FHKAM 3505 3307 wingyanmak@cuhk.edu.hk
Prince of Wales Hospital, Shatin
Hong Kong, Hong Kong
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
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