A Randomised-controlled Trial of an Oral Microbiome Immunity Formula in Recovered COVID-19 Patients
NCT ID: NCT04950803
Last Updated: 2024-08-22
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
448 participants
INTERVENTIONAL
2021-06-25
2027-12-31
Brief Summary
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Detailed Description
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Natural infection by virus triggers an effective system immunity so that the host can resist or highly reduce the chance of re-infection.
In many cases, this protection can maintain a long period of time. However, the long-term immunities (over a year) and complications from the patients are not yet very clear. We found that COVID-19 survivors who have cleared the virus continued to have persistent altered gut microbiota and up to 80 percent had residue COVID-19 related symptoms including fatigue, difficulty in breathing, impaired memory and hair loss up to 6 months after discharge (LONG COVID-19).
Earlier studies from our CU Medicine have shown a link between altered gut microbiome and COVID-19 severity, and more patients who received a novel microbiome immunity formula (SIM01) achieved complete symptom resolution and developed neutralising antibody than those who did not (unpublished data). Research from the Faculty also reported that almost 40% of people in Hong Kong had significant gut dysbiosis especially in elderly and patients with diabetes, obesity or chronic diseases.
This study is a single-centre, triple-blind, randomized, placebo-controlled clinical trial that aims to evaluate the effectiveness of an oral microbiome immunity formula (SIM01) invented by the Chinese University of Hong Kong (CUHK) in modulating gut microbiota, enhancing immunity and reducing long-term complications and co-morbidities (e.g. sepsis, cardiopulmonary complications, metabolic syndrome, neuropsychiatric disorders) in patients who have recovered from COVID-19.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Active arm
Subjects will take microbiome immunity formula (SIM01) daily for 6 months
Microbiome immunity formula
Microbiome immunity formula contains probiotics blend (3Bifidobacteria, 20 billion CFU daily)
Placebo arm
Subjects will take active vitamin daily for 6 months
Active placebo
Active placebo contains active vitamin
Interventions
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Microbiome immunity formula
Microbiome immunity formula contains probiotics blend (3Bifidobacteria, 20 billion CFU daily)
Active placebo
Active placebo contains active vitamin
Eligibility Criteria
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Inclusion Criteria
2. Subjects who are mentally capable to participate in the study and provide informed consent;
3. Subjects who can communicate in Chinese or English;
4. Subjects who are ambulatory and do not have difficulties travelling to the clinics for follow-up;
5. Subjects who do not have plans to leave Hong Kong in the subsequent two years after recruitment; and
6. Subjects who agree to give informed consent voluntarily.
Exclusion Criteria
2. Subjects who have received surgery involving the intestine within past 30 days;
3. Subjects who are pregnant or breastfeeding; and
4. Subjects who are immunocompromised, e.g. on cancer treatment, bone marrow/organ transplant, immune deficiency, poorly controlled HIV/AIDS.
18 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Siew Chien NG
Professor
Principal Investigators
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Siew Ng
Role: PRINCIPAL_INVESTIGATOR
CUHK-M&T
Locations
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Prince of Wales Hospital
Hong Kong, , Hong Kong
Countries
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References
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Related Links
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Hong Kong Government website
Quality of Life and Long-term Outcomes After Hospitalization for COVID-19.
Other Identifiers
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RECOVERY
Identifier Type: -
Identifier Source: org_study_id
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