ClinicalTrials.gg
CompletedNCT05432180Updated Mar 6, 2025

Human Milk Nutrients and Infants' Health Outcomes in South China

An observational study in Healthy, sponsored by Huilian Zhu. Completed at 1 site in China. Open to participants aged 4 Years to 5 Years. Per ClinicalTrials.gov, last updated 2025-03-06.

Sponsored by Huilian Zhu · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
4 Years to 5 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Healthy
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In context

Lead sponsor

Huilian Zhu is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children of this study will be recruited from lactating women provided human milk samples before.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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 serious violation of the scheme no longer meet the research criteria because of health factors or accidents
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. The growth of children

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

    Time frame: 18 month

  2. The cognitive development of children

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

    Time frame: 18 month

  3. Gut microbiota

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

    Time frame: 6 month

Secondary outcomes

  1. General demographic materials

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

    Time frame: 14 month

  2. Dietary and lifestyle information

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

    Time frame: 3 month

  3. Behavior problems

    The behavior problems are collected by Child Behavior Checklist.

    Time frame: 18 month

  4. Allergic assessment

    Allergic assessments of children will be conducted by questionnaire.

    Time frame: 18 month

  5. Sleep assessment

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

    Time frame: 18 month

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Study locations

1 site
  • Sun Yat-sen University
    Guangzhou, Guangdong 510080, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05432180
Lead sponsor
Huilian Zhu
Responsible party
Huilian Zhu (Professor, Sun Yat-sen University) — Sponsor-investigator
First posted
Jun 27, 2022
Start date
Jun 6, 2022
Primary completion
Oct 30, 2023
Completion
Dec 30, 2023
Last update
Mar 6, 2025

Study contacts

Huilian Zhu, Professor
study chair · Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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