An Evaluation of a Synbiotic Formula for Patients With COVID-19 Infection
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Health supplements + standard care 28 days of health supplements (Synbiotic) daily plus standard care |
Other: Health supplements
28 days of health supplements (synbiotic), 4g daily
|
| No Intervention: Standard care No intervention |
Outcome Measures
Primary Outcome Measures
- Combined symptom score [4 weeks]
Combined symptom score improvement of the first 4 weeks. Symptoms score assessment ranges from 20-80. The higher the score, the worse the symptoms.
Secondary Outcome Measures
- Clinical improvement [4 weeks]
Compare the number and severity of symptoms existing by checking the list in symptoms assessment such as cough, shortness of breath, fever and gastrointestinal symptoms like anorexia, nausea, vomiting, abdominal pain, bloating before and during the study
- Time to develop antibody against SARS-CoV-2 [16 days]
Compare the time to develop antibody against SARS-CoV-2 in both group
- Quality of life measured by EQ-5D-5L [4 weeks]
Improvement of quality of life measured by EQ-5D-5L. EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The index can be calculated by deducting the appropriate weights from 1, the value for full health (i.e. state 11111). Each category ranges from 1 to 5. The small the number, the better the health. The EQ-VAS is a vertical visual analogue scale that ranges 0-100 (higher score indicates better imaginable health).
- Quality of life measured by SF-12 [4 weeks]
Improvement of quality of life measured by SF-12. SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. There are formulas for transformation of scale scores so that they will range from 0-100. High score in functioning items indicates better functioning while high score in pain items indicates freedom from pain.
- Duration of hospital stay [up to 3 months]
Measure the duration of hospital stay in both group
- Time to negative PCR [through study completion, an average of 1 year]
Compare the time to negative PCR in both group
- Trend of symptom score [4 weeks]
Trend of symptom score, ranges from 26-104. The higher the score, the worse the symptoms.
- Gastrointestinal symptoms [4 weeks]
Duration of gastrointestinal symptoms such as anorexia, nausea, vomiting, abdominal pain, bloating within 4 week.
- Changes in fecal bacteria metabolites [weeks 2, 4, 5 and 8 months 3, 6, 9 and 12]
Changes in fecal bacteria metabolites measured by PCR at different time points
- Change in plasma cytokines level [week 2 and week 5]
Change in plasma cytokines level at week 2 and week 5 compared with baseline
- Changes in the gut microbiome [weeks 1, 2, 3, 4, 5, 8 and months 3, 6, 9 and 12]
Changes in the gut microbiome (bacteria, virome and fungome) measured by metagenomics at different time points (weeks 1, 2, 3, 4, 5 and months 3, 6, 9 and 12) compared to baseline
- Number of admission to Intensive Care Unit [4 weeks]
Number of admission to Intensive Care Unit
- Number of subjects with home discharge [4 weeks]
Number of subjects with home discharge
- Number of mortality [4 weeks]
Number of mortality
- Number of days absent from work [3 months]
Number of days absent from work since admission
- Change of quality of life questionnaire [week 8, months 3, 6, 9 and 12]
Change in score on Quality of life using EQ-5D-5L and SF-12. EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The index can be calculated by deducting the appropriate weights from 1, the value for full health (i.e. state 11111). Each category ranges from 1 to 5. The small the number, the better the health. The EQ-VAS is a vertical visual analogue scale that ranges 0-100 (higher score indicates better imaginable health). While the SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. There are formulas for transformation of scale scores so that they will range from 0-100. High score in functioning items indicates better functioning while high score in pain items indicates freedom from pain.
- Number of adverse event [3 months]
Number of adverse event
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged 18 or above; and
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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
-
Written informed consent is obtained
Exclusion Criteria:
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Subjects admitted to Intensive Care Unit or on ventilator
-
Known allergy or intolerance to the intervention product or its components
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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)
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Known increased infection risk due to immunosuppression such as:
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Prior organ or hematopoietic stem cell transplant
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Neutropenia (ANC <500 cells/ul)
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HIV and CD4 <200 cells/ul
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Known history or active endocarditis
-
Recent on CAPD or hemodialysis-
-
Documented pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Chinese University of Hong Kong | Sha Tin | Hong Kong | 000000 |
Sponsors and Collaborators
- Siew Chien NG
Investigators
- Principal Investigator: Siew Chien Ng, Chinese University of Hong Kong
Study Documents (Full-Text)
None provided.More Information
Publications
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- Synbiotic COV study