The Association of Gut Microbiota With COVID 19 Infection in Children

May 18, 2023 updated by: Ky Young Cho, Hallym University Kangnam Sacred Heart Hospital

The Association of Gut Microbiota With Early Infection Stages of COVID-19 in Children

Although COVID-19 infects gastrointestinal tissues, little is known about the roles of gut commensal microbes in susceptibility to and severity of infection. The investigators will analyze the alterations in fecal microbiomes of patients with COVID-19 infection during hospitalization.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

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

Study Contact

Study Locations

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

3 months to 15 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Those who were hospitalized because of the COVID 19 were enrolled.

Description

Inclusion Criteria:

  • patients infected with COVID 19

Exclusion Criteria:

  • congenital heart, renal, intestinal disease
  • malignancy
  • immunologic disease

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with COVID 19
Pediatric patient infected by COVID 19
Diagnostic test: 16S rRNA sequencing
Fecal microbiome analysis using 16S rRNA sequencing
Pediatric patient without infection of COVID 19
Diagnostic test: 16S rRNA sequencing
Fecal microbiome analysis using 16S rRNA sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The analysis of fecal microbiome of patient with COVID 19
Time Frame: through study completion, an average of 1 year
The analysis of fecal microbiome of patient with COVID 19, using 16S rRNA sequencing
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Hallym University Kangnam Sacred Heart Hospital

Investigators

  • Principal Investigator: KY YOUNG CHO, MD, PhD, Hallym University Kangnam Sacred Heart Hospital

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)

April 14, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Covid 19 and Gut Microbiota

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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