Scientists track breast milk changes in 769 chinese moms
NCT ID NCT05235412
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed study followed 769 healthy Chinese mothers and their babies for six months after birth. Researchers measured how breast milk composition (like protein, fat, and carbohydrates) changed over time and tracked infant growth. The goal was to better understand the link between maternal diet, milk content, and baby health outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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769 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Jul 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Generally healthy mothers with the intention to breastfeed, and their infants.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Mothers: 1. Generally healthy mothers with the intention to breastfeed. 2. Aged 18 years and above. 3. Written informed consent. Infants: 1. Generally healthy term born (gestational age between 37 and 42 weeks). 2. Breastfed by their mothers, either exclusively or in combination with infant milk formula, at enrolment. 3. Chinese ethnicity of mother and father. Exclusion Criteria: Mothers: 1. Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study. 2. Difficulty to follow up and/or locate (e.g. known transfer to other hospitals, residing outside the city where the study site is located, or planning to move out of the current city; incapability of mothers to comply with study protocol or investigator' s uncertainty about the willingness or ability of the mothers to understand and comply with the protocol requirements. 3. Illegal drug use. 4. Regular smoking and/ or consumption of alcoholic beverages as per investigator's judgement. 5. A BMI of \<18.5 or ≥ 28 pre-pregnancy or during the first regular pregnancy check around or before 16 weeks of gestational age. 6. Acute infectious disease or neoplastic disease or any kind of weakening or debilitating conditions (with history of positive, hepatitis C virus (HCV) or HIV serological test at any time during the pregnancy). 7. Presence of mastitis, fungal infections of the nipple or areola; reactivation of herpes simplex (HSV) or varicella zoster infection in the mammary or thoracic region at the time of enrolment. 8. Presence of chronic diseases such as endocrine, cardiovascular, renal, respiratory or hepatic diseases. 9. Presence of psychosis and severe post-partum depression. 10. Presence of autoimmune disease such as systemic lupus erythematosus, systemic scleroderma, ulcerative colitis, Crohn's disease, celiac disease. 11. Women whose health condition, according to the investigator's judgement, could interfere with the study conduction and assessment. 12. Mothers who have given birth to twins or multiples or infant conceived with Assisted Reproductive Technology (ART). Infants: 1. Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study. 2. At enrolment, any congenital abnormality, chromosomal disorder or severe disease which could interfere with the study conduct and assessment. 3. Consumption of food other than breast milk or infant formula. 4. Fully formula fed at enrolment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Nanjing Medical University Jiangning Campus
Nanjing, Jiangsu, 211166, China
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Other studies related to the condition(s) this trial covers.
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