Official Title
An Evaluation of a Synbiotic Formula for Symptom Improvement in Hospitalised Patients With COVID-19 Infection
Brief Summary

In December 2019, a cluster of pneumonia cases of unidentified cause emerged in Wuhan,was identified as the culprit of this disease currently being identified as "Coronavirus Disease 2019" (COVID-19) by World Health Organization. Coronavirus was found to not only target the patient's lungs but also multiple organs. Around 2-33% of Coronavirus Disease-19 patients developed gastrointestinal symptoms. Studies have shown that Severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) was found in patient's feces, suggesting that the virus can spread through feces. In our previous study, stool samples from 15 patients with COVID-19 were analysed. Depleted symbionts and gut dysbiosis were noted even after patients were detected negative of SARS-CoV-2. A series of microbiota were correlated inversely with the disease severity and virus load. Gut microbiota could play a role in modulating host immune response and potentially influence disease severity and outcomes. The investigators are uncertain about the impact of synbiotic on patients with COVID-19. However, a therapeutic strategy aiming at investigating the gut Imicrobiota of patients with COVID-9 who take synbiotic or not, leading to lesser progression to severe disease, less hospital stay and improved quality of life.

Detailed Description

In December 2019, a cluster of pneumonia cases of unidentified cause emerged in Wuhan, Hubei
province, China. In early January, a novel betacoronavirus forming another clade within the
subgenus sarbecovirus, now named SARS-CoV-2, was identified as the culprit of this disease
currently being identified as "Coronavirus Disease 2019" (COVID-19) by WHO.

Coronavirus was found to not only target the patient's lungs, but also multiple organs.
Around 2-33% of COVID-19 patients developed gastrointestinal symptoms. Studies have shown
that SAR-CoV-2 was found in patient's feces, suggesting that the virus can spread through
feces. In our previous study, stool samples from 15 patients with COVID-19 were analysed.
Depleted symbionts and gut dysbiosis were noted even after patients were detected negative of
SARS-CoV-2. A series of microbiota were correlated inversely with the disease severity and
virus load. Gut microbiota could play a role in modulating host immune response and
potentially influence disease severity and outcomes.

In July 2020, there are more than 15 million confirmed cases globally with 620 thousand
deaths. Currently, there are more than 2000 confirmed cases of COVID-19 in Hong Kong. The
investigators are uncertain about the impact of synbiotic on patients with COVID-19. However,
a therapeutic strategy aiming at investigating the gut Imicrobiota of patients with COVID-9
who take synbiotic or not, leading to lesser progression to severe disease, less hospital
stay and improved quality of life.

Enrolling by invitation
COVID19
Microbiota

Other: Health supplements

28 days of health supplements (synbiotic), 4g daily

Eligibility Criteria

Inclusion Criteria:

1. Aged 18 or above; and

2. A confirmed diagnosis of SARS-CoV-2 infection using the PCR according to the standard
of according to Centre for Health Protection, Department of Health, HK at recruitment
and that require admission to the hospitalization area; and

3. Written informed consent is obtained

Exclusion Criteria:

1. Subjects admitted to Intensive Care Unit or on ventilator

2. Known allergy or intolerance to the intervention product or its components

3. Any known medical condition that would prevent taking oral probiotics or increase
risks associated with probiotics including but not limited to inability to
swallow/aspiration risk and no other methods of delivery (e.g no G/J tube)

4. Known increased infection risk due to immunosuppression such as:

- Prior organ or hematopoietic stem cell transplant

- Neutropenia (ANC <500 cells/ul)

- HIV and CD4 <200 cells/ul

5. Known history or active endocarditis

6. Recent on CAPD or hemodialysis-

7. Documented pregnancy

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Hong Kong
Locations

The Chinese University of Hong Kong
Sha Tin, Hong Kong

Siew Chien Ng, Principal Investigator
Chinese University of Hong Kong

Siew Chien NG
NCT Number
MeSH Terms
COVID-19