Human MicrobiomeNCT06812091
Human Microbiome Research and Development for Overcoming Pediatric Diseases
An observational study of Human Microbiome and Pediatrics, run by Hanyang University at 1 site in South Korea.
Trial summary
Prediction and treatment of pediatric diseases and long-term outcomes through microbiome and multi-omics analysis by life cycle: We aim to demonstrate that a wide range of diseases are associated with gut microbiome dysbiosis and to investigate the subsequent recovery (restoration) or further deterioration of the gut… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Human Microbiome, Pediatrics, Disease
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2022to 1 Jan 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Control group: healthy infants without any diagnosed diseases, born full-term, exhibiting normal growth and development. Case group: infants with diagnosed diseases, including those born prematurely, those with a history of neonatal intensive care unit (NICU) admission, and those exhibiting neurodevelopmental impairments.
Who may be able to join
- children (including newborns) who have obtained their consent from their guardians
Who cannot join
- subjects who did not obtain consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University Medical Center
Seoul, 04763
Hyun-Kyung Park, MD, 82-10-4749-1454, neopark@hanyang.ac.kr
About this study
Official title: Prediction and Treatment of Pediatric Diseases and Long-term Outcomes Through Microbiome and Multi-Omics Study by Life Cycle
Prediction and treatment of pediatric diseases and long-term outcomes through microbiome and multi-omics analysis by life cycle: We aim to demonstrate that a wide range of diseases are associated with gut microbiome dysbiosis and to investigate the subsequent recovery (restoration) or further deterioration of the gut microbiome over time. This study seeks to offer a novel perspective on changes in the gut microbiome, particularly in the context of the gut-lung and gut-brain axes.
Read the detailed description
Fecal samples are collected and analyzed from birth through childhood, including those from both preterm and term infants. Based on these collected samples, groups are categorized into disease groups commonly observed in children. Genomic DNA is extracted from the fecal samples, followed by high-throughput 16S rRNA amplicon sequencing to analyze the microbial composition. Additionally, multiomics analyses, including metabolomics, are conducted to provide a comprehensive understanding of gut microbiome dynamics. The impact on the microbiome is further investigated in vitro using a fermenter-based intestinal microbiota model system.
- Conditions
- Human Microbiome, Pediatrics, Disease, Growth & Development
- Medical subject headings
- Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up of growth percentile in height, weight, and head circumference
Monitoring the baby's growth status compared to the Nomogram growth chart
Measured: 2 months old, 4 months old, 6 months old, 1 year old, and then every year until the age of ten years
Obervation of age-specific developmental milestones
Judging whether the development status is appropriate according to developmental milestones based on developmental screening tests and doctors' opinions)
Measured: 4 months old, 1 year old, 3 years old, school age
Observations on the incidence and frequency of enteritis, sepsis, and respiratory diseases
The dysbiosis of the gut microbiome affects various organs, such as the gut-lung axis and the gut-brain axis, in addition to the disease of the intestine itself, so monitor the occurrence of infectious diseases
Measured: 2 months old, 4 months old, 6 months old, 1 year old, and then every year until the age of ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Jan 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human MicrobiomeStudies 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
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Kyung Park, Hanyang University
- Investigators
- Hyun-Kyung Park, MD, Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812091
- Sponsor's protocol ID
- HYUMC IRB No. 2023-04-047
- Status last verified
- Feb 2025
- First submitted
- 2 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Treatment of Pediatric Diseases and Long-term Outcomes Through Microbiome and Multi-Omics Study by Life Cycle
- ClinicalTrials.gov ID
- NCT06812091
- Acronym / sponsor ID
- HYUMC IRB No. 2023-04-047
- Conditions
- Human Microbiome, Pediatrics, Disease, Growth & Development
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 6 Feb 2025 (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.
Prediction and treatment of pediatric diseases and long-term outcomes through microbiome and multi-omics analysis by life cycle: We aim to demonstrate that a wide range of diseases are associated with gut microbiome dysbiosis and to investigate the subsequent recovery (restoration) or further deterioration of the gut microbiome over time. This study seeks to offer a novel perspective on changes in the gut microbiome, particularly in the context of the gut-lung and gut-brain axes.
Detailed description
Fecal samples are collected and analyzed from birth through childhood, including those from both preterm and term infants. Based on these collected samples, groups are categorized into disease groups commonly observed in children. Genomic DNA is extracted from the fecal samples, followed by high-throughput 16S rRNA amplicon sequencing to analyze the microbial composition. Additionally, multiomics analyses, including metabolomics, are conducted to provide a comprehensive understanding of gut microbiome dynamics. The impact on the microbiome is further investigated in vitro using a fermenter-based intestinal microbiota model system.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Control group: healthy infants without any diagnosed diseases, born full-term, exhibiting normal growth and development. Case group: infants with diagnosed diseases, including those born prematurely, those with a history of neonatal intensive care unit (NICU) admission, and those exhibiting neurodevelopmental impairments.
Key inclusion criteria (1 listed)
- children (including newborns) who have obtained their consent from their guardians
Key exclusion criteria (1 listed)
- subjects who did not obtain consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Follow-up of growth percentile in height, weight, and head circumference
Time frame: 2 months old, 4 months old, 6 months old, 1 year old, and then every year until the age of ten years
Monitoring the baby's growth status compared to the Nomogram growth chart
Obervation of age-specific developmental milestones
Time frame: 4 months old, 1 year old, 3 years old, school age
Judging whether the development status is appropriate according to developmental milestones based on developmental screening tests and doctors' opinions)
Observations on the incidence and frequency of enteritis, sepsis, and respiratory diseases
Time frame: 2 months old, 4 months old, 6 months old, 1 year old, and then every year until the age of ten years
The dysbiosis of the gut microbiome affects various organs, such as the gut-lung axis and the gut-brain axis, in addition to the disease of the intestine itself, so monitor the occurrence of infectious diseases
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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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.
Hyun-Kyung Park, MD principal investigator
Hanyang University
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 Human Microbiome and Pediatrics, run by Hanyang University 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 1 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: looking for participants now, as of the sponsor's last update on 6 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Kyung Park, MD (82-10-4749-1454, neopark@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow-up of growth percentile in height, weight, and head circumference (time frame: 2 months old, 4 months old, 6 months old, 1 year old, and then every year until the age of ten years). The study lists 3 primary outcomes in all. 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 6 Feb 2025.