Evaluation of a Synbiotic Formula in Patient With COVID-19

Not Applicable

• Conditions: Coronavirus
• Interventions: Other: Health supplements

• Registration Number: NCT04730284
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2020-08-25
• Study First Submitted: 2020-08-25
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-28
• Last Update Submitted: 2021-01-28
• Study First Posted: 2021-01-29
• Last Update Posted: 2021-01-29
• Primary Completion: 2021-09-30
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health supplements	Health supplements	One arm only

Primary Outcome Measures

Name	Time	Method
Changes in gut microbiome	week 5	Changes in the gut microbiome (bacteria, virome and fungome) measured by metagenomics at week 5 compared to baseline

Secondary Outcome Measures

Name	Time	Method
Changes in fecal bacteria metabolites	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	week 5	Change in plasma cytokines level at week 5 compared with baseline
Change in Quality of life measured by SF-12	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	4 weeks	Duration of gastrointestinal symptoms such as anorexia, nausea, vomiting, abdominal pain, bloating within 4 weeks.
Trend in symptom score	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	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).
Adverse event assessment	3 months	Number of adverse event

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong