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Completed

NCT Number: NCT05432180

Human Milk Nutrients and Infants' Health Outcomes in South China

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

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Key information

Conditions

Healthy

Age range

4 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The growth of children

    Time frame: 18 month

    The physical growth and body composition of children will be checked by physical examination.

  2. The cognitive development of children

    Time frame: 18 month

    The brain developments of children will be obtained by the Griffith Developmental Assessment Scale.

  3. Gut microbiota

    Time frame: 6 month

    Gut microbiota of children will be examined by the analysis of 16S rDNA and metagenomic.

Secondary outcomes

  1. General demographic materials

    Time frame: 14 month

    The general demographic materials of parents and children will be obtained by questionnaire.

  2. Dietary and lifestyle information

    Time frame: 3 month

    Dietary and lifestyle information of children will be obtained by questionnaire.

  3. Behavior problems

    Time frame: 18 month

    The behavior problems are collected by Child Behavior Checklist.

  4. Allergic assessment

    Time frame: 18 month

    Allergic assessments of children will be conducted by questionnaire.

  5. Sleep assessment

    Time frame: 18 month

    Sleep assessment of infants will be conducted by The Children's Sleep Health Questionnaire.

Sponsors and collaborators

Lead sponsor

Huilian Zhu

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 27, 2022
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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