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Clinical Trials in China / NCT06854536
Active, not recruiting Observational

A Study on the Changes and Prognosis of Intestinal Microbiota and Function in Infants With Food Allergies

NCT06854536 · tracked via the Priya Life Science China tracker
Sponsor
Ruijin Hospital
Phase
Observational
Started
2025-02-01
Last updated
2025-03-03

Condition(s) studied

HealthChildrenGut Microbiota

Study summary

Microorganisms maintain a complex interrelationship with the human body, influencing each other. In recent years, people have gradually realized that the formation of the pediatric microecosystem is closely related to the development of gastrointestinal and even systemic immunity in children. The establishment of the pediatric microecosystem during childhood has significant implications for various diseases in adulthood. They are crucial for the host's nutrition, metabolism, resistance to pathogens, and immune function. Increasing evidence supports the association between gut microbiota abnormalities and the pathophysiology of food allergies, but the conclusions of existing clinical efficacy studies remain controversial. Previous research by the team has found that the gut microbiome has a clear impact on the occurrence and development of digestive and allergic diseases in children.

Eligibility

Sex
ALL
Min age
1 Month
Max age
36 Months
Healthy volunteers
Accepted
Inclusion Criteria: * Children aged 1-36 months old * Both men and women; * The child's legal guardian signed the informed consent to participate in the study. * The legal guardian of the child commits to follow the study procedures and cooperate with the entire study process Exclusion Criteria: * Probiotics or antibiotics within 1 month * Associated with clinically significant abnormalities in liver and kidney function, nervous system, respiratory system, and coagulation function as determined by the investigator * Unstable vital signs; * Have other underlying medical conditions * Individuals deemed unsuitable for this clinical trial.

Primary outcome measure(s)

  • Intestinal microbiome analysis — The time point of confirming food allergy and the age of 36 months
    The fecal samples from all participants will be collected and subjected to high-throughput metagenomic sequencing in order to elucidate the characteristics and composition of the intestinal microbiome in children with food allergies.
  • Intestinal microbiome metabolites analysis — The time point of confirming food allergy and the age of 36 months
    This will be detected and analyzed by liquid chromatography-mass spectrometry (LC-MS) non-targeted metabolomics to analyze the metabolites of the intestinal microbiome.

Trial sites (1)

FacilityCityRegionStatus
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06854536 on ClinicalTrials.gov ↗ ← All trials in China