The Association of Gut Microbiota With COVID 19 Infection in Children

Sponsor
Hallym University Kangnam Sacred Heart Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05303155
Collaborator
(none)
40
21

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 16S rRNA sequencing

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Association of Gut Microbiota With Early Infection Stages of COVID-19 in Children
Anticipated Study Start Date :
Apr 14, 2022
Anticipated Primary Completion Date :
Jan 14, 2023
Anticipated Study Completion Date :
Jan 14, 2024

Arms and Interventions

Arm 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

Pediatric patient without infection of COVID 19

Diagnostic Test: 16S rRNA sequencing
Fecal microbiome analysis using 16S rRNA sequencing

Outcome Measures

Primary Outcome Measures

  1. The analysis of fecal microbiome of patient with COVID 19 [through study completion, an average of 1 year]

    The analysis of fecal microbiome of patient with COVID 19, using 16S rRNA sequencing

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Months to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • patients infected with COVID 19
Exclusion Criteria:
  • congenital heart, renal, intestinal disease

  • malignancy

  • immunologic disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hallym University Kangnam Sacred Heart Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hallym University Kangnam Sacred Heart Hospital
ClinicalTrials.gov Identifier:
NCT05303155
Other Study ID Numbers:
  • Covid 19 and Gut Microbiota
First Posted:
Mar 31, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022