NCT04884776

Modulation of Gut Microbiota to Enhance Health and Immunity

Status unknown NA Last updated 29 December 2022

What this trial tests

NA trial testing Microbiome immunity formula in Gut Microbiota in 453 participants. Status unknown.

Timeline

1 June 2021

Primary endpoint
31 May 2024

31 May 2024

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	453
Start date	1 June 2021
Primary completion	31 May 2024
Estimated completion	31 May 2024
Sites	1 location across Hong Kong

Drugs / interventions tested

• Microbiome immunity formula
• Active placebo

Conditions studied

• Gut Microbiota — all drugs for Gut Microbiota →
• COVID-19 Vaccine — all drugs for COVID-19 Vaccine →

Sponsor

Chinese University of Hong Kong

Who can join

18 and older, any sex, with Gut Microbiota or COVID-19 Vaccine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evidences and perspectives of the use of probiotics, prebiotics, synbiotics, and postbiotics as adjuvants for prevention and treatment of COVID-19: A bibliometric analysis and systematic review.
   Xavier-Santos D, Padilha M, Fabiano GA, Vinderola G, et al · · 2022 · cited 76× · PMID 35002079 · DOI 10.1016/j.tifs.2021.12.033
2. Role of Gut Microbiome in COVID-19: An Insight Into Pathogenesis and Therapeutic Potential.
   Hussain I, Cher GLY, Abid MA, Abid MB. · · 2021 · cited 53× · PMID 34721437 · DOI 10.3389/fimmu.2021.765965
3. Probiotics and prebiotics: potential prevention and therapeutic target for nutritional management of COVID-19?
   Batista KS, de Albuquerque JG, Vasconcelos MHA, Bezerra MLR, et al · · 2023 · cited 33× · PMID 34668465 · DOI 10.1017/s0954422421000317
4. Gut Dysbiosis during COVID-19 and Potential Effect of Probiotics.
   Hung YP, Lee CC, Lee JC, Tsai PJ, et al · · 2021 · cited 32× · PMID 34442684 · DOI 10.3390/microorganisms9081605
5. Targeting the Gut Microbiota in Coronavirus Disease 2019: Hype or Hope?
   Lau HC, Ng SC, Yu J. · · 2022 · cited 16× · PMID 34508775 · DOI 10.1053/j.gastro.2021.09.009
6. Oral SARS-CoV-2 Spike Protein Recombinant Yeast Candidate Prompts Specific Antibody and Gut Microbiota Reconstruction in Mice.
   Zhang L, Yao L, Guo Y, Li X, et al · · 2022 · cited 14× · PMID 35464985 · DOI 10.3389/fmicb.2022.792532
7. A comprehensive perspective on the interaction between gut microbiota and COVID-19 vaccines.
   Hong M, Lan T, Li Q, Li B, et al · · 2023 · cited 13× · PMID 37431857 · DOI 10.1080/19490976.2023.2233146
8. Effects of Gut Microbiome Modulation on Reducing Adverse Health Outcomes among Elderly and Diabetes Patients during the COVID-19 Pandemic: A Randomised, Double-Blind, Placebo-Controlled Trial (IMPACT Study).
   Wong MCS, Zhang L, Ching JYL, Mak JWY, et al · · 2023 · cited 13× · PMID 37111201 · DOI 10.3390/nu15081982