Modulation of Gut Microbiota to Enhance Health and Immunity

NCT04884776 | Unknown

• 1 other identifier: IMPACT Study
• Study Type: interventional
• Target: 453
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiota; COVID-19 Vaccine

Outcome Measures

Primary Outcomes (1)

• Adverse events/Serious adverse events

  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 Outcomes (7)

• Immunogenicity of the COVID-19 vaccine

  3 months and 6 months

• Change in gut microbiome

  1, 3, 6, and 12 months

• Changes in plasma inflammatory cytokines

  3 months and 6 months

• Restoration of gut dysbiosis

  1, 3, 6 and 12 months

• Number of unscheduled hospitalisation and clinic visits

  1, 3, 6, and 12 months

Study Arms (2)

Active arm

ACTIVE COMPARATOR

Subject will be instructed to take microbiome immunity formula 2 sachets daily for a total of 12 weeks.

Dietary Supplement: Microbiome immunity formula

Placebo arm

PLACEBO COMPARATOR

Subject will be instructed to take active placebo daily for a total of 12 weeks.

Dietary Supplement: Active placebo

Interventions

Microbiome immunity formula DIETARY_SUPPLEMENT

Microbiome immunity formula contains probiotics blend (3 Bifidobacteria, 10 billion CFU per sachet)

Active arm

Active placebo DIETARY_SUPPLEMENT

Active placebo contains active vitamin

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years - below 65 years
• A confirmed diagnosis of type 2 DM for ≥ 3 months with stable control (i.e. no change in DM medications in recent 2 months)
• Written informed consents obtained

You may not qualify if:

• Known history of confirmed COVID-19 infection
• Known active sepsis or active malignancy
• Known increased infection risk due to underlying immunosuppressed state which includes:
• Prior organ or hematopoietic stem cell transplant
• On concomitant immunosuppressants or corticosteroid at a dose of prednisolone equivalent dose 10mg or more for more than 3 months
• Known history or active infective endocarditis
• On peritoneal dialysis or haemodialysis
• Documented pregnancy
• Substudy 2
• Age 65 years and above
• Written informed consents obtained
• Known history of confirmed COVID-19 infection
• Known active sepsis or active malignancy
• Known increased infection risk due to underlying immunosuppressed state which includes:
• Prior organ or hematopoietic stem cell transplant

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, Shatin

Hong Kong, Hong Kong

Location

Related Publications (29)

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Study Officials

• Joyce WY Mak, FHKAM

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 13, 2021
• Study Start: June 1, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)