Human Microbiome Research and Development for Overcoming Pediatric Diseases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHanyang University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

children (including newborns) who have obtained their consent from their guardians

Disqualifiers

subjects who did not obtain consent

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Follow-up of growth percentile in height, weight, and head circumference

Monitoring the baby's growth status compared to the Nomogram growth chart

Time frame
2 months old, 4 months old, 6 months old, 1 year old, and then every year until the age of ten years
2

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)

Time frame
4 months old, 1 year old, 3 years old, school age
3

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

Time frame
2 months old, 4 months old, 6 months old, 1 year old, and then every year until the age of ten years

Secondary outcomes

Other outcomes

Sponsors and contacts

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