CompletedNot Applicable

A Cohort Study on Milk Composition, Health Outcomes, and Feeding Practices of Chinese Mothers and Infants

China769 participantsStarted 2021-11-19

Plain-language summary

This is a cohort study to understand the changes of breastmilk composition in the first six months after birth of Chinese infants.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Generally healthy mothers with the intention to breastfeed.
. Aged 18 years and above.
. Written informed consent.
. Generally healthy term born (gestational age between 37 and 42 weeks).
. Breastfed by their mothers, either exclusively or in combination with infant milk formula, at enrolment.
. Chinese ethnicity of mother and father.

Exclusion criteria

. Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study.
. 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.
. Illegal drug use.
. Regular smoking and/ or consumption of alcoholic beverages as per investigator's judgement.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in human milk protein concentration

Timeframe: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in human milk fat concentration

Timeframe: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in human milk carbohydrate concentration

Timeframe: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in human milk energy content

Timeframe: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in infant length

Timeframe: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in infant head circumference

Timeframe: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Trial details

NCT IDNCT05235412

SponsorDanone Nutricia

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-07-31

View on ClinicalTrials.gov More Breast Feeding trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Generally healthy mothers with the intention to breastfeed.
. Aged 18 years and above.
. Written informed consent.
. Generally healthy term born (gestational age between 37 and 42 weeks).
. Breastfed by their mothers, either exclusively or in combination with infant milk formula, at enrolment.
. Chinese ethnicity of mother and father.

Exclusion criteria

. Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study.
. 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.
. Illegal drug use.
. Regular smoking and/ or consumption of alcoholic beverages as per investigator's judgement.

What they're measuring

Changes in human milk protein concentration

Timeframe: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in human milk fat concentration

Timeframe: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in human milk carbohydrate concentration

Timeframe: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in human milk energy content

Timeframe: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in infant length

Timeframe: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in infant head circumference

Timeframe: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth