Human Milk Nutrients and Infants' Health Outcomes in South China

Completed

• Conditions: Healthy

• Registration Number: NCT05432180
• Lead Sponsor: Huilian Zhu

Brief Summary

The purpose of this study is to investigate the associations between human milk nutrients and infants' health outcomes in China.

Detailed Description

Human milk components are beneficial to the growth and development of infants, such as phospholipids, gangliosides, sialic acids, choline, oligosaccharide and so on. However, studies on the associations between human milk components and infants' outcomes are limited. Therefore, this study is designed to investigate the relationship between Chinese human milk components and the growth and development of infants.

Study Timeline

• Study Start: 2022-06-06
• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-27
• Primary Completion: 2023-10-30
• Study Completion: 2023-12-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• age 4-5 years
• healthy children
• breastfeeding between 0 to 400 days of age
• human milk components in human milk being determined
• sign informed consent

Exclusion Criteria

• children with severe chronic diseases, such as tumor, severe digestive diseases, kidney diseases
• gestational diabetes, hypertension and other metabolic diseases
• children with mental system diseases
• children with congenital and genetic diseases
• children with infectious diseases, eg, upper respiratory tract infection or diarrhea
• antibiotic or other drugs influencing intestinal flora being taken within 45 days
• Withdraw withdraw informed consent serious violation of the scheme no longer meet the research criteria because of health factors or accidents

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The growth of children	18 month	The physical growth and body composition of children will be checked by physical examination.
The cognitive development of children	18 month	The brain developments of children will be obtained by the Griffith Developmental Assessment Scale.
Gut microbiota	6 month	Gut microbiota of children will be examined by the analysis of 16S rDNA and metagenomic.

Secondary Outcome Measures

Name	Time	Method
Allergic assessment	18 month	Allergic assessments of children will be conducted by questionnaire.
Dietary and lifestyle information	3 month	Dietary and lifestyle information of children will be obtained by questionnaire.
General demographic materials	14 month	The general demographic materials of parents and children will be obtained by questionnaire.
Behavior problems	18 month	The behavior problems are collected by Child Behavior Checklist.
Sleep assessment	18 month	Sleep assessment of infants will be conducted by The Children's Sleep Health Questionnaire.

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China