Gut MicrobiotaNCT04884776
Modulation of Gut Microbiota to Enhance Health and Immunity
A study testing Microbiome immunity formula in people with Gut Microbiota and COVID-19 Vaccine, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gut Microbiota, COVID-19 Vaccine
- What is being tested?
- Microbiome immunity formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 453 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2021to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Age 65 years and above
- Written informed consents obtained
Who cannot join
- 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
- 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
Show all 22Show fewer
- 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
- 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
- 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
- Known history or active infective endocarditis
- On peritoneal dialysis or haemodialysis
- Known active malignancy
- Known terminal illness with life expectancy less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gut Microbiota, COVID-19 Vaccine
- Being tested
- Microbiome immunity formula, Active placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiome immunity formulaDietary supplement
Microbiome immunity formula contains probiotics blend (3 Bifidobacteria, 10 billion CFU per sachet)
Active placeboDietary supplement
Active placebo contains active vitamin
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Active comparator | Subject will be instructed to take microbiome immunity formula 2 sachets daily for a total of 12 weeks. Receives: Dietary Supplement: Microbiome immunity formula |
| Placebo arm | Placebo comparator | Subject will be instructed to take active placebo daily for a total of 12 weeks. Receives: Dietary Supplement: Active placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 6 months
Secondary outcomes (7)
Immunogenicity of the COVID-19 vaccine
Measured by serum neutralization assay against pseudo virus and live virus, and IgM and IgG against receptor-binding domain [RBD] and S1
Measured: 3 months and 6 months
Change in gut microbiome
Measured the gut microbiome changes by metagenomic sequencing and metabolite profiling by targeted and/or untargeted metabolites profiling
Measured: 1, 3, 6, and 12 months
Changes in plasma inflammatory cytokines
Measured the inflammatory cytokines (CRP or ESR) in blood result
Measured: 3 months and 6 months
Restoration of gut dysbiosis
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
Measured: 1, 3, 6 and 12 months
Number of unscheduled hospitalisation and clinic visits
Number of unscheduled hospitalisation and clinic visits
Measured: 1, 3, 6, and 12 months
Changes of quality of life
Measured the score of EQ-5D-5L which measure the health-related quality of life
Measured: 1, 3, 6, and 12 months
Changes in glycaemic control
Measured by HbA1c
Measured: 1, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Jun 2021
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mak Wing Yan, Chinese University of Hong Kong
- Investigators
- Joyce WY Mak, FHKAM, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884776
- Sponsor's protocol ID
- IMPACT Study
- Status last verified
- Dec 2022
- First submitted
- 29 Apr 2021
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076McGurnaghan SJ, Weir A, Bishop J, Kennedy S, Blackbourn LAK, McAllister DA, Hutchinson S, Caparrotta TM, Mellor J, Jeyam A, O'Reilly JE, Wild SH, Hatam S, Hohn A, Colombo M, Robertson C, Lone N, Murray J, Butterly E, Petrie J, Kennon B, McCrimmon R, Lindsay R, Pearson E, Sattar N, McKnight J, Philip S, Collier A, McMenamin J, Smith-Palmer A, Goldberg D, McKeigue PM, Colhoun HM; Public Health Scotland COVID-19 Health Protection Study Group; Scottish Diabetes Research Network Epidemiology Group. Risks of and risk factors for COVID-19 disease in people with diabetes: a cohort study of the total population of Scotland. Lancet Diabetes Endocrinol. 2021 Feb;9(2):82-93. doi: 10.1016/S2213-8587(20)30405-8. Epub 2020 Dec 23.
PubMed 33357491Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.
PubMed 32320003Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.
PubMed 32250385Apicella M, Campopiano MC, Mantuano M, Mazoni L, Coppelli A, Del Prato S. COVID-19 in people with diabetes: understanding the reasons for worse outcomes. Lancet Diabetes Endocrinol. 2020 Sep;8(9):782-792. doi: 10.1016/S2213-8587(20)30238-2. Epub 2020 Jul 17.
PubMed 32687793Quan J, Li TK, Pang H, Choi CH, Siu SC, Tang SY, Wat NMS, Woo J, Johnston JM, Leung GM. Diabetes incidence and prevalence in Hong Kong, China during 2006-2014. Diabet Med. 2017 Jul;34(7):902-908. doi: 10.1111/dme.13284. Epub 2016 Nov 29.
PubMed 27859570Mueller AL, McNamara MS, Sinclair DA. Why does COVID-19 disproportionately affect older people? Aging (Albany NY). 2020 May 29;12(10):9959-9981. doi: 10.18632/aging.103344. Epub 2020 May 29.
PubMed 32470948Marquez EJ, Chung CH, Marches R, Rossi RJ, Nehar-Belaid D, Eroglu A, Mellert DJ, Kuchel GA, Banchereau J, Ucar D. Sexual-dimorphism in human immune system aging. Nat Commun. 2020 Feb 6;11(1):751. doi: 10.1038/s41467-020-14396-9.
PubMed 32029736Jaillon S, Berthenet K, Garlanda C. Sexual Dimorphism in Innate Immunity. Clin Rev Allergy Immunol. 2019 Jun;56(3):308-321. doi: 10.1007/s12016-017-8648-x.
PubMed 28963611Yeoh YK, Zuo T, Lui GC, Zhang F, Liu Q, Li AY, Chung AC, Cheung CP, Tso EY, Fung KS, Chan V, Ling L, Joynt G, Hui DS, Chow KM, Ng SSS, Li TC, Ng RW, Yip TC, Wong GL, Chan FK, Wong CK, Chan PK, Ng SC. Gut microbiota composition reflects disease severity and dysfunctional immune responses in patients with COVID-19. Gut. 2021 Apr;70(4):698-706. doi: 10.1136/gutjnl-2020-323020. Epub 2021 Jan 11.
PubMed 33431578Segal JP, Mak JWY, Mullish BH, Alexander JL, Ng SC, Marchesi JR. The gut microbiome: an under-recognised contributor to the COVID-19 pandemic? Ther Adv Gastroenterol. 2020 Nov 24;13:1756284820974914. doi: 10.1177/1756284820974914. eCollection 2020.
PubMed 33281941Zhang X, Tan Y, Ling Y, Lu G, Liu F, Yi Z, Jia X, Wu M, Shi B, Xu S, Chen J, Wang W, Chen B, Jiang L, Yu S, Lu J, Wang J, Xu M, Yuan Z, Zhang Q, Zhang X, Zhao G, Wang S, Chen S, Lu H. Viral and host factors related to the clinical outcome of COVID-19. Nature. 2020 Jul;583(7816):437-440. doi: 10.1038/s41586-020-2355-0. Epub 2020 May 20.
PubMed 32434211Zuo T, Zhang F, Lui GCY, Yeoh YK, Li AYL, Zhan H, Wan Y, Chung ACK, Cheung CP, Chen N, Lai CKC, Chen Z, Tso EYK, Fung KSC, Chan V, Ling L, Joynt G, Hui DSC, Chan FKL, Chan PKS, Ng SC. Alterations in Gut Microbiota of Patients With COVID-19 During Time of Hospitalization. Gastroenterology. 2020 Sep;159(3):944-955.e8. doi: 10.1053/j.gastro.2020.05.048. Epub 2020 May 20.
PubMed 32442562Zuo T, Liu Q, Zhang F, Lui GC, Tso EY, Yeoh YK, Chen Z, Boon SS, Chan FK, Chan PK, Ng SC. Depicting SARS-CoV-2 faecal viral activity in association with gut microbiota composition in patients with COVID-19. Gut. 2021 Feb;70(2):276-284. doi: 10.1136/gutjnl-2020-322294. Epub 2020 Jul 20.
PubMed 32690600Belkaid Y, Hand TW. Role of the microbiota in immunity and inflammation. Cell. 2014 Mar 27;157(1):121-41. doi: 10.1016/j.cell.2014.03.011.
PubMed 24679531
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Gut Microbiota to Enhance Health and Immunity of Vulnerable Individuals During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04884776
- Acronym / sponsor ID
- IMPACT Study
- Conditions
- Gut Microbiota, COVID-19 Vaccine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active arm | Active comparator | Dietary Supplement: Microbiome immunity formulaSubject will be instructed to take microbiome immunity formula 2 sachets daily for a total of 12 weeks. |
| Placebo arm | Placebo comparator | Dietary Supplement: Active placeboSubject will be instructed to take active placebo daily for a total of 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Age 65 years and above
- Written informed consents obtained
Key exclusion criteria (22 listed)
- Known history of confirmed COVID-19 infection
- Known active sepsis or active malignancy
- Known increased infection risk due to underlying immunosuppressed state which includes:
- Known history or active infective endocarditis
- On peritoneal dialysis or haemodialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiome immunity formulaMicrobiome immunity formula contains probiotics blend (3 Bifidobacteria, 10 billion CFU per sachet) | Dietary supplement | Active arm |
| Active placeboActive placebo contains active vitamin | Dietary supplement | Placebo arm |
Primary outcome
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
7 secondary outcomes
Immunogenicity of the COVID-19 vaccine
Time frame: 3 months and 6 months
Change in gut microbiome
Time frame: 1, 3, 6, and 12 months
Changes in plasma inflammatory cytokines
Time frame: 3 months and 6 months
Restoration of gut dysbiosis
Time frame: 1, 3, 6 and 12 months
Number of unscheduled hospitalisation and clinic visits
Time frame: 1, 3, 6, and 12 months
Changes of quality of life
Time frame: 1, 3, 6, and 12 months
Changes in glycaemic control
Time frame: 1, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Background: PubMed 32171076Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
- Background: PubMed 33357491McGurnaghan SJ, Weir A, Bishop J, Kennedy S, Blackbourn LAK, McAllister DA, Hutchinson S, Caparrotta TM, Mellor J, Jeyam A, O'Reilly JE, Wild SH, Hatam S, Hohn A, Colombo M, Robertson C, Lone N, Murray J, Butterly E, Petrie J, Kennon B, McCrimmon R, Lindsay R, Pearson E, Sattar N, McKnight J, Philip S, Collier A, McMenamin J, Smith-Palmer A, Goldberg D, McKeigue PM, Colhoun HM; Public Health Scotland COVID-19 Health Protection Study Group; Scottish Diabetes Research Network Epidemiology Group. Risks of and risk factors for COVID-19 disease in people with diabetes: a cohort study of the total population of Scotland. Lancet Diabetes Endocrinol. 2021 Feb;9(2):82-93. doi: 10.1016/S2213-8587(20)30405-8. Epub 2020 Dec 23.
- Background: PubMed 32320003Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.
- Background: PubMed 32250385Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.
- Background: PubMed 32687793Apicella M, Campopiano MC, Mantuano M, Mazoni L, Coppelli A, Del Prato S. COVID-19 in people with diabetes: understanding the reasons for worse outcomes. Lancet Diabetes Endocrinol. 2020 Sep;8(9):782-792. doi: 10.1016/S2213-8587(20)30238-2. Epub 2020 Jul 17.
- Background: PubMed 27859570Quan J, Li TK, Pang H, Choi CH, Siu SC, Tang SY, Wat NMS, Woo J, Johnston JM, Leung GM. Diabetes incidence and prevalence in Hong Kong, China during 2006-2014. Diabet Med. 2017 Jul;34(7):902-908. doi: 10.1111/dme.13284. Epub 2016 Nov 29.
- Background: PubMed 32470948Mueller AL, McNamara MS, Sinclair DA. Why does COVID-19 disproportionately affect older people? Aging (Albany NY). 2020 May 29;12(10):9959-9981. doi: 10.18632/aging.103344. Epub 2020 May 29.
- Background: PubMed 32029736Marquez EJ, Chung CH, Marches R, Rossi RJ, Nehar-Belaid D, Eroglu A, Mellert DJ, Kuchel GA, Banchereau J, Ucar D. Sexual-dimorphism in human immune system aging. Nat Commun. 2020 Feb 6;11(1):751. doi: 10.1038/s41467-020-14396-9.
- Background: PubMed 28963611Jaillon S, Berthenet K, Garlanda C. Sexual Dimorphism in Innate Immunity. Clin Rev Allergy Immunol. 2019 Jun;56(3):308-321. doi: 10.1007/s12016-017-8648-x.
- Background: PubMed 33431578Yeoh YK, Zuo T, Lui GC, Zhang F, Liu Q, Li AY, Chung AC, Cheung CP, Tso EY, Fung KS, Chan V, Ling L, Joynt G, Hui DS, Chow KM, Ng SSS, Li TC, Ng RW, Yip TC, Wong GL, Chan FK, Wong CK, Chan PK, Ng SC. Gut microbiota composition reflects disease severity and dysfunctional immune responses in patients with COVID-19. Gut. 2021 Apr;70(4):698-706. doi: 10.1136/gutjnl-2020-323020. Epub 2021 Jan 11.
- Background: PubMed 33281941Segal JP, Mak JWY, Mullish BH, Alexander JL, Ng SC, Marchesi JR. The gut microbiome: an under-recognised contributor to the COVID-19 pandemic? Ther Adv Gastroenterol. 2020 Nov 24;13:1756284820974914. doi: 10.1177/1756284820974914. eCollection 2020.
- Background: PubMed 32434211Zhang X, Tan Y, Ling Y, Lu G, Liu F, Yi Z, Jia X, Wu M, Shi B, Xu S, Chen J, Wang W, Chen B, Jiang L, Yu S, Lu J, Wang J, Xu M, Yuan Z, Zhang Q, Zhang X, Zhao G, Wang S, Chen S, Lu H. Viral and host factors related to the clinical outcome of COVID-19. Nature. 2020 Jul;583(7816):437-440. doi: 10.1038/s41586-020-2355-0. Epub 2020 May 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce WY Mak, FHKAM principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microbiome immunity formula in people with Gut Microbiota and COVID-19 Vaccine, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events/Serious adverse events (time frame: within 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04884776, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.