An Evaluation of a Synbiotic Formula for Patients With COVID-19 Infection

NCT04581018 | Unknown DMC

• 1 other identifier: Synbiotic COV study
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19; Microbiota

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (17)

• Clinical improvement

  4 weeks

• Time to develop antibody against SARS-CoV-2

  16 days

• Quality of life measured by EQ-5D-5L

  4 weeks

• Quality of life measured by SF-12

  4 weeks

• Duration of hospital stay

  up to 3 months

Study Arms (2)

Health supplements + standard care

ACTIVE COMPARATOR

28 days of health supplements (Synbiotic) daily plus standard care

Other: Health supplements

Standard care

NO INTERVENTION

No intervention

Interventions

Health supplements OTHER

28 days of health supplements (synbiotic), 4g daily

Health supplements + standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or above; and
• 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 at recruitment and that require admission to the hospitalization area; and
• Written informed consent is obtained

You may not qualify if:

• Subjects admitted to Intensive Care Unit or on ventilator
• Known allergy or intolerance to the intervention product or its components
• 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)
• 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
• Known history or active endocarditis
• Recent on CAPD or hemodialysis-
• Documented pregnancy

Sponsors & Collaborators

• Siew Chien NG: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, 000000, Hong Kong

Location

Related Publications (14)

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• WHO Coronavirus Disease (COVID-19) Dashboard. [Assessed on 24 Jul 2020]. https://covid19.who.int/

  BACKGROUND

• Latest situation of cases of COVID-19. [Assessed on 24 Jul 2020]. https://www.chp.gov.hk/files/pdf/local_situation_covid19_en.pdf

  BACKGROUND

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• Liang JQ, Zeng Y, Lau EYT, Sun Y, Huang Y, Zhou T, Xu Z, Yu J, Ng SC, Chan FKL. A Probiotic Formula for Modulation of Colorectal Cancer Risk via Reducing CRC-Associated Bacteria. Cells. 2023 Apr 25;12(9):1244. doi: 10.3390/cells12091244.

  PMID: 37174650 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Siew Chien Ng

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: October 9, 2020
• Study Start: August 13, 2020
• Primary Completion: December 31, 2021
• Study Completion: July 31, 2023
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)