ClinicalTrials.gg
RecruitingNCT05303155Updated May 19, 2023

The Association of Gut Microbiota With COVID 19 Infection in Children

An observational study in Coronavirus Infections, Gut Microbiome and Childhood ALL, sponsored by Hallym University Kangnam Sacred Heart Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 3 Months to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-19.

Sponsored by Hallym University Kangnam Sacred Heart Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Apr 2022; still recruiting 4 years 6 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
3 Months to 15 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 13 studies in Coronavirus Infections with a site in Korea, Republic of — 5 open to participants now, 6 under way, 4 of them phase 3. Coronavirus Infections · Korea, Republic of.

Started
2022
with 1 other
Observational
3 of 13
1 open now
Registered
9th of 13
by date
Lead sponsor
1 of 13
Hallym University Kangnam Sacred Heart Hospital

Among the 13 studies in Coronavirus Infections with a site in Korea, Republic of, this one is one of 2 that started in 2022, is one of 3 observational ones, and was the 9th registered.

Coronavirus Infections

1,112 studies on the registry are indexed under Coronavirus Infections; 52 are open to participants now.

Browse Coronavirus Infections studies →

Open to participants now

5 of the 13 studies in Coronavirus Infections with a site in Korea, Republic of are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 40 Coronavirus Infections studies recruiting now, 24 (60%) set no upper age limit and 9 (23%) stop at 75 or younger; 13 take children under 18; 20 take healthy volunteers.

This study: 3 Months to 15 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • Coronavirus Infections
  • Gut Microbiome
  • Childhood ALL
04

Who can participate

Ages eligible
3 Months to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients infected with COVID 19

Exclusion criteria

Exclusion Criteria:

  • congenital heart, renal, intestinal disease
  • immunologic disease
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patient with COVID 19

    Pediatric patient infected by COVID 19

    Diagnostic Test: 16S rRNA sequencing

  • Pediatric patient without infection of COVID 19

    Pediatric patient without infection of COVID 19

    Diagnostic Test: 16S rRNA sequencing

Interventions

  • Diagnostic test16S rRNA sequencing

    Fecal microbiome analysis using 16S rRNA sequencing

06

What researchers measure

Primary outcomes

  1. The analysis of fecal microbiome of patient with COVID 19

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

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2022 (actual). Primary completion is estimated for Dec 2023, 20 months after the start.

Of 228 non-industry observational studies under Coronavirus Infections, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 20 months is above that.

Counting every sponsor, half of 245 studies reached it within 14 months; a quarter within 5 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2022
First posted
Mar 31, 2022
StartActual
Apr 14, 2022
Primary completionEst.
Dec 31, 2023
CompletionEst.
Dec 31, 2024
Last update
May 19, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05303155
Lead sponsor
Hallym University Kangnam Sacred Heart Hospital
Responsible party
Ky Young Cho (M.D., Ph.D., Hallym University Kangnam Sacred Heart Hospital) — Principal investigator
First posted
Mar 31, 2022
Start date
Apr 14, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
May 19, 2023

Study contacts

KY YOUNG CHO, MD, PhD
Contact
choky96@naver.com
821090910197
KY YOUNG CHO, MD, PhD
principal investigator · Hallym University Kangnam Sacred Heart Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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