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

NCT06854536 | Active Not Recruiting

• 1 other identifier: GMSF-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Health; Children; Gut Microbiota

Outcome Measures

Primary Outcomes (2)

• Intestinal microbiome analysis

  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.

  The time point of confirming food allergy and the age of 36 months

• Intestinal microbiome metabolites analysis

  This will be detected and analyzed by liquid chromatography-mass spectrometry (LC-MS) non-targeted metabolomics to analyze the metabolites of the intestinal microbiome.

  The time point of confirming food allergy and the age of 36 months

Secondary Outcomes (4)

• Differences in clinical symptoms

  36 months of age

• The percentile number of height of children at different groups

  The time point of confirming food allergy and the age of 36 months

• The percentile number of head circumference of children at different group

  The time point of confirming food allergy and the age of 36 months

• The percentile number of weight of children at different groups

  The time point of confirming food allergy and the age of 36 months

Study Arms (1)

Food-allergic children

Children diagnosed with food allergies

Eligibility Criteria

• Age: 1 Month - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosed with food allergy children aged 1-36 months old

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

faeces

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: March 3, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

CN (1)