An interventional study of Health supplements in Covid19 and Microbiota, sponsored by Siew Chien NG. Status unknown at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by Siew Chien NG · Not applicable, Interventional, and Supportive care
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Siew Chien NG as lead sponsor.
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Exclusion Criteria:
Known increased infection risk due to immunosuppression such as:
28 days of health supplements (Synbiotic) daily plus standard care
Other: Health supplements
No intervention
28 days of health supplements (synbiotic), 4g daily
Combined symptom score
Combined symptom score improvement of the first 4 weeks. Symptoms score assessment ranges from 20-80. The higher the score, the worse the symptoms.
Time frame: 4 weeks
Clinical improvement
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 frame: 4 weeks
Time to develop antibody against SARS-CoV-2
Compare the time to develop antibody against SARS-CoV-2 in both group
Time frame: 16 days
Quality of life measured by EQ-5D-5L
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).
Time frame: 4 weeks
Quality of life measured by SF-12
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.
Time frame: 4 weeks
Duration of hospital stay
Measure the duration of hospital stay in both group
Time frame: up to 3 months
Time to negative PCR
Compare the time to negative PCR in both group
Time frame: through study completion, an average of 1 year
Trend of symptom score
Trend of symptom score, ranges from 26-104. The higher the score, the worse the symptoms.
Time frame: 4 weeks
Gastrointestinal symptoms
Duration of gastrointestinal symptoms such as anorexia, nausea, vomiting, abdominal pain, bloating within 4 week.
Time frame: 4 weeks
Changes in fecal bacteria metabolites
Changes in fecal bacteria metabolites measured by PCR at different time points
Time frame: weeks 2, 4, 5 and 8 months 3, 6, 9 and 12
Change in plasma cytokines level
Change in plasma cytokines level at week 2 and week 5 compared with baseline
Time frame: week 2 and week 5
Changes in the gut microbiome
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
Time frame: weeks 1, 2, 3, 4, 5, 8 and months 3, 6, 9 and 12
Number of admission to Intensive Care Unit
Number of admission to Intensive Care Unit
Time frame: 4 weeks
Number of subjects with home discharge
Number of subjects with home discharge
Time frame: 4 weeks
Number of mortality
Number of mortality
Time frame: 4 weeks
Number of days absent from work
Number of days absent from work since admission
Time frame: 3 months
Change of quality of life questionnaire
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.
Time frame: week 8, months 3, 6, 9 and 12
Number of adverse event
Number of adverse event
Time frame: 3 months
Plan to share: No
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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