NCT05432180

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

June 20, 2022

Last Update Submit

March 3, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • The growth of children

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

    18 month

  • The cognitive development of children

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

    18 month

  • Gut microbiota

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

    6 month

Secondary Outcomes (5)

  • General demographic materials

    14 month

  • Dietary and lifestyle information

    3 month

  • Behavior problems

    18 month

  • Allergic assessment

    18 month

  • Sleep assessment

    18 month

Eligibility Criteria

Age4 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

  • Yang MT, Lan QY, Pan C, Huang SY, Huang ZH, Li MC, Li Z, Li F, Li X, Zou JP, Chen HQ, Qiu YZ, Song S, Mao YY, Zhu HL. Long-term cognitive benefits of human milk phospholipids in breastfed children at preschool age: results from MUAI study. Eur J Nutr. 2025 Sep 23;64(7):283. doi: 10.1007/s00394-025-03801-y.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Faeces were retented.

Study Officials

  • Huilian Zhu, Professor

    Sun Yat-sen University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 20, 2022

First Posted

June 27, 2022

Study Start

June 6, 2022

Primary Completion

October 30, 2023

Study Completion

December 30, 2023

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations