Evaluation of a Synbiotic Formula in Patient With COVID-19
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|ClinicalTrials.gov Identifier: NCT04730284|
Recruitment Status : Recruiting
First Posted : January 29, 2021
Last Update Posted : January 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus||Other: Health supplements||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of a Synbiotic Formula in Patient With COVID-19|
|Actual Study Start Date :||August 25, 2020|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||March 31, 2022|
Experimental: Health supplements
One arm only
Other: Health supplements
tailor-made Synbiotics, 4g per day for 28 days
- Changes in gut microbiome [ Time Frame: week 5 ]Changes in the gut microbiome (bacteria, virome and fungome) measured by metagenomics at week 5 compared to baseline
- Changes in fecal bacteria metabolites [ Time Frame: weeks 2, 4, 5, 8 and months 3, 6, 9 and 12 ]Changes in fecal bacteria metabolites by PCR at different time points
- Change in plasma cytokines including IL-6, IL-IB, TNF-a and CXCL-10 [ Time Frame: week 5 ]Change in plasma cytokines level at week 5 compared with baseline
- Trend in symptom score [ Time Frame: weeks 2, 4, 5, 8 and months 3, 6, 9 and 12 ]Trend of symptom score at different time points, ranges from 26-104. The higher the score, the worse the symptoms.
- Change in Quality of life measured by EQ-5D-5L [ Time Frame: weeks 2, 4, 5, 8 and months 3, 6, 9 and 12 ]Change in score on Quality of life using EQ-5D-5L at different time points. 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).
- Change in Quality of life measured by SF-12 [ Time Frame: weeks 2, 4, 5, 8 and months 3, 6, 9 and 12 ]Change in score on Quality of life using SF-12 at different time points. 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 gastrointestinal symptoms [ Time Frame: 4 weeks ]Duration of gastrointestinal symptoms such as anorexia, nausea, vomiting, abdominal pain, bloating within 4 weeks.
- Adverse event assessment [ Time Frame: 3 months ]Number of adverse event
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04730284
|Contact: Kristy Ho, Bscemail@example.com|
|Contact: Kitty Cheung, MPHfirstname.lastname@example.org|
|Chinese University of Hong Kong||Recruiting|
|Hong Kong, Hong Kong|
|Principal Investigator:||Siew Ng, PhD||Chinese University of Hong Kong|