Coronavirus InfectionsNCT05303155
The Association of Gut Microbiota With COVID 19 Infection in Children
An observational study of Coronavirus Infections and Gut Microbiome, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infections, Gut Microbiome, Childhood ALL
- What is being tested?
- 16S rRNA sequencing
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Apr 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Those who were hospitalized because of the COVID 19 were enrolled.
Who may be able to join
- patients infected with COVID 19
Who cannot join
- congenital heart, renal, intestinal disease
- malignancy
- immunologic disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07440
Ky Young Cho, Ph.D., choky96@hallym.or.kr
About this study
Official title: 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.
- Conditions
- Coronavirus Infections, Gut Microbiome, Childhood ALL
- Being tested
- 16S rRNA sequencing
- Medical subject headings
- Coronavirus Infections, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16S rRNA sequencingDiagnostic test
Fecal microbiome analysis using 16S rRNA sequencing
| Study group | Role | What they receive |
|---|---|---|
| Patient with COVID 19 | Pediatric patient infected by COVID 19 Receives: Diagnostic Test: 16S rRNA sequencing | |
| Pediatric patient without infection of COVID 19 | Pediatric patient without infection of COVID 19 Receives: Diagnostic Test: 16S rRNA sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The analysis of fecal microbiome of patient with COVID 19
The analysis of fecal microbiome of patient with COVID 19, using 16S rRNA sequencing
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start14 Apr 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ky Young Cho, Hallym University Kangnam Sacred Heart Hospital
- Investigators
- KY YOUNG CHO, MD, PhD, Principal investigator, Hallym University Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303155
- Sponsor's protocol ID
- Covid 19 and Gut Microbiota
- Status last verified
- May 2023
- First submitted
- 18 Mar 2022
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Gut Microbiota With Early Infection Stages of COVID-19 in Children
- ClinicalTrials.gov ID
- NCT05303155
- Acronym / sponsor ID
- Covid 19 and Gut Microbiota
- Conditions
- Coronavirus Infections, Gut Microbiome, Childhood ALL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with COVID 19 | – | Diagnostic Test: 16S rRNA sequencingPediatric patient infected by COVID 19 |
| Pediatric patient without infection of COVID 19 | – | Diagnostic Test: 16S rRNA sequencingPediatric patient without infection of COVID 19 |
Who may qualify
- Ages
- 3 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Those who were hospitalized because of the COVID 19 were enrolled.
Key inclusion criteria (1 listed)
- patients infected with COVID 19
Key exclusion criteria (3 listed)
- congenital heart, renal, intestinal disease
- malignancy
- immunologic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 16S rRNA sequencingFecal microbiome analysis using 16S rRNA sequencing | Diagnostic test | Patient with COVID 19, Pediatric patient without infection of COVID 19 |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KY YOUNG CHO, MD, PhD principal investigator
Hallym University Kangnam Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infections and Gut Microbiome, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KY YOUNG CHO, MD, PhD (821090910197, choky96@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The analysis of fecal microbiome of patient with COVID 19 (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.