Official Title
Evaluation of a Synbiotic Formula in Patient With COVID-19
Brief Summary

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.

Detailed Description

Coronavirus can target multiple organs due to the hyperactive immune response with cytokine
storms. Several studies have detected SARS-CoV-2 in stool samples and indicated that the
virus could spread via faeces. Importantly, COVID-19 uses the same receptor as SARS and this
doorway can also be found in the intestine. The cell entry receptor, known as angiotensin
converting enzyme 2 (ACE2) receptor mediate entry of SARS-CoV-2 and is highly expressed in
small bowel enterocytes. ACE2 is important in controlling intestinal inflammation and its
disruption may lead to diarrhoea. 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 billion confirmed cases globally with 620 thousand
deaths. Currently, there are more than 2000 confirmed cases of COVID-19 in Hong Kong. It is
important to rebalance the gut microbiota in COVID-19 patients and to improve the symptoms
and the quality of life of these patients.

Unknown status
Coronavirus

Other: Health supplements

tailor-made Synbiotics, 4g per day for 28 days

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 and released
from isolation at recruitment.

3. Written informed consent obtained

Exclusion Criteria:

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

2. 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)

3. 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

4. Known increased infection risk due to endovascular due to:

- Rheumatic heart disease

- Congenital heart defect,

- Mechanical heart valves

- Endocarditis

- Endovascular grafts

- Permanent endovascular devices such as permanent (not short-term) hemodialysis
catheters, pacemakers, or defibrillators

5. Documented pregnancy

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

Chinese University of Hong Kong
Hong Kong, Hong Kong

Contacts

Kristy Ho, Bsc
85235053855
hiutungho@cuhk.edu.hk

Kitty Cheung, MPH
85226373225
kittyccy@cuhk.edu.hk

Siew Ng, PhD, Principal Investigator
Chinese University of Hong Kong

Chinese University of Hong Kong
NCT Number
Keywords
Microbiota
MeSH Terms
Coronavirus Infections