Evaluation of a Synbiotic Formula in Patient With COVID-19

January 28, 2021 updated by: Siew Chien NG, Chinese University of Hong Kong
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Health supplements
One arm only
Other: Health supplements
tailor-made Synbiotics, 4g per day for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
week 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
weeks 2, 4, 5, 8 and months 3, 6, 9 and 12
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
week 5
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.
weeks 2, 4, 5, 8 and months 3, 6, 9 and 12
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).
weeks 2, 4, 5, 8 and months 3, 6, 9 and 12
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.
weeks 2, 4, 5, 8 and months 3, 6, 9 and 12
Duration of gastrointestinal symptoms
Time Frame: 4 weeks
Duration of gastrointestinal symptoms such as anorexia, nausea, vomiting, abdominal pain, bloating within 4 weeks.
4 weeks
Adverse event assessment
Time Frame: 3 months
Number of adverse event
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 25, 2020

Primary Completion (ANTICIPATED)

September 30, 2021

Study Completion (ANTICIPATED)

March 31, 2022

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

January 28, 2021

First Posted (ACTUAL)

January 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVSyn

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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