Viewing Study NCT04581018



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Last Modification Date: 2024-10-26 @ 1:46 PM
Study NCT ID: NCT04581018
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2022-11-03
First Post: 2020-08-11

Brief Title: An Evaluation of a Synbiotic Formula for Patients With COVID-19 Infection
Sponsor: Siew Chien NG
Organization: Chinese University of Hong Kong

Study Overview

Official Title: An Evaluation of a Synbiotic Formula for Symptom Improvement in Hospitalised Patients With COVID-19 Infection
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2022-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: In December 2019 a cluster of pneumonia cases of unidentified cause emerged in Wuhanwas 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 patients 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 patients 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
Detailed Description: In December 2019 a cluster of pneumonia cases of unidentified cause emerged in Wuhan Hubei province China In early January a novel betacoronavirus forming another clade within the subgenus sarbecovirus now named SARS-CoV-2 was identified as the culprit of this disease currently being identified as Coronavirus Disease 2019 COVID-19 by WHO

Coronavirus was found to not only target the patients lungs but also multiple organs Around 2-33 of COVID-19 patients developed gastrointestinal symptoms Studies have shown that SAR-CoV-2 was found in patients 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

In July 2020 there are more than 15 million confirmed cases globally with 620 thousand deaths Currently there are more than 2000 confirmed cases of COVID-19 in Hong Kong 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None