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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
Sponsor:
Information provided by (Responsible Party):
Siew Chien NG, 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.

Condition or disease Intervention/treatment Phase
Coronavirus Other: Health supplements Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
Experimental: Health supplements
One arm only
Other: Health supplements
tailor-made Synbiotics, 4g per day for 28 days




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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).

  5. 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.

  6. Duration of gastrointestinal symptoms [ Time Frame: 4 weeks ]
    Duration of gastrointestinal symptoms such as anorexia, nausea, vomiting, abdominal pain, bloating within 4 weeks.

  7. Adverse event assessment [ Time Frame: 3 months ]
    Number of adverse event



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Kristy Ho, Bsc 85235053855 hiutungho@cuhk.edu.hk
Contact: Kitty Cheung, MPH 85226373225 kittyccy@cuhk.edu.hk

Locations
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Hong Kong
Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Siew Ng, PhD Chinese University of Hong Kong
Publications:
WHO Coronavirus Disease (COVID-19) Dashboard. [Assessed on 24 Jul 2020]. https://covid19.who.int/

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Responsible Party: Siew Chien NG, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04730284    
Other Study ID Numbers: COVSyn
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Siew Chien NG, Chinese University of Hong Kong:
microbiota
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases