Human Milk Nutrients and Infants' Health Outcomes in South China

Healthy Clinical Trial

Official title:

Human Milk Nutrients and Infants' Health Outcomes in South China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05432180
• Other study ID #: MUAI-2022
• Status: Recruiting
• Start date: June 6, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2022
• Source: Sun Yat-sen University
• Contact: Huilian Zhu, Professor
• Phone: +86 20 87331811
• Email: zhuhl[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

Inclusion Criteria:

• age 3-5 years
• healthy children
• breastfeeding at least until 40-45 days of age
• human milk components in mature milk (40-45days) 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

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Huilian Zhu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The growth of children	The physical growth and body composition of children will be checked by physical examination.	18 month
Primary	The cognitive development of children	The brain developments of children will be obtained by the Griffith Developmental Assessment Scale.	18 month
Primary	Gut microbiota	Gut microbiota of children will be examined by the analysis of 16S rDNA and metagenomic.	6 month
Secondary	General demographic materials	The general demographic materials of parents and children will be obtained by questionnaire.	14 month
Secondary	Dietary and lifestyle information	Dietary and lifestyle information of children will be obtained by questionnaire.	3 month
Secondary	Behavior problems	The behavior problems are collected by Child Behavior Checklist.	18 month
Secondary	Allergic assessment	Allergic assessments of children will be conducted by questionnaire.	18 month
Secondary	Sleep assessment	Sleep assessment of infants will be conducted by The Children's Sleep Health Questionnaire.	18 month