Breast FeedingPhoenixNCT05235412
A Cohort Study on Milk Composition, Health Outcomes, and Feeding Practices of Chinese Mothers and Infants
An observational study of Breast Feeding and Breast Milk Expression, run by Danone Nutricia at 1 site in China.
Trial summary
This is a cohort study to understand the changes of breastmilk composition in the first six months after birth of Chinese infants. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Breast Milk Expression
- What is being tested?
- Not applicable: Observational study without any interventions.
- How many people
- 769 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2021to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Generally healthy mothers with the intention to breastfeed, and their infants.
Who may be able to join
- Mothers:
- Generally healthy mothers with the intention to breastfeed.
- Aged 18 years and above.
- Written informed consent.
- Infants:
- 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.
Who cannot join
- Mothers:
- 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.
- A BMI of <18.5 or ≥ 28 pre-pregnancy or during the first regular pregnancy check around or before 16 weeks of gestational age.
Show all 18Show fewer
- 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).
- 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.
- Presence of chronic diseases such as endocrine, cardiovascular, renal, respiratory or hepatic diseases.
- Presence of psychosis and severe post-partum depression.
- Presence of autoimmune disease such as systemic lupus erythematosus, systemic scleroderma, ulcerative colitis, Crohn's disease, celiac disease.
- Women whose health condition, according to the investigator's judgement, could interfere with the study conduction and assessment.
- Mothers who have given birth to twins or multiples or infant conceived with Assisted Reproductive Technology (ART).
- Infants:
- Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study.
- At enrolment, any congenital abnormality, chromosomal disorder or severe disease which could interfere with the study conduct and assessment.
- Consumption of food other than breast milk or infant formula.
- Fully formula fed at enrolment.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Medical University Jiangning Campus
Nanjing, Jiangsu, 211166
About this study
This is a cohort study to understand the changes of breastmilk composition in the first six months after birth of Chinese infants.
Read the detailed description
The relationship of breastmilk composition, the maternal gut microbiome and lifestyle factors such as diet, feeding practices and physical activity and the infant's health and gut microbiome will be investigated in this study.
- Conditions
- Breast Feeding, Breast Milk Expression
- Being tested
- Not applicable: Observational study without any interventions.
- Medical subject headings
- Breast Feeding, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable: Observational study without any interventions.Other
Exposures of interest: Maternal diet and lifestyle, demographics, anthropometrics, infant's health outcomes
| Study group | Role | What they receive |
|---|---|---|
| Chinese mothers with the intention to breastfeed, and their infants. | Observational study. Receives: Other: Not applicable: Observational study without any interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in human milk protein concentration
Protein concentration in g/l of human milk will be analyzed
Measured: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Changes in human milk fat concentration
Fat concentration in g/l of human milk will be analyzed
Measured: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Changes in human milk carbohydrate concentration
Carbohydrate concentration in g/l of human milk will be analyzed
Measured: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Changes in human milk energy content
Energy content in kCal/l of human milk will be analyzed
Measured: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Changes in infant length
Length measured in cm
Measured: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Changes in infant head circumference
Head circumference measured in cm
Measured: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Changes in infant weight
Weight measured in grams
Measured: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Secondary outcomes (10)
Variations in human milk microbiome
Analyzed by sequencing
Measured: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Variations in human milk micronutrients
Analyzed by mass spectrometry
Measured: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Variations in human milk oligosaccharides (HMOs)
Analyzed by mass spectrometry
Measured: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Variations in human milk lipid composition
Analyzed by mass spectrometry
Measured: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Variations in human milk amino acids and proteins
Analyzed by mass spectrometry
Measured: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Variations in infant fecal microbiome
Analyzed by sequencing
Measured: Infant fecal samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Variations in maternal fecal microbiome
Analyzed by sequencing
Measured: Maternal fecal samples collected at 1 month, 3 month, 6 months, 12 months after infant birth
Changes in infant stool consistency and frequency
Data will be collected via diaries using the Brussel Infant and Toddler Stool Scale
Measured: Data collected at 1 month, 3 month, 6 months, 12 months after infant birth
Changes in infant feeding practices
Dietary data will be collected via questionnaires
Measured: Data collected at 1 month, 3 month, 6 months, 12 months,2 years after infant birth
Changes in maternal body mass index
Maternal weight and height will be combined to determine body mass index [kg/m2]
Measured: Data collected at 1 month, 3 month, 6 months, 12 months 2 years after infant birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start19 Nov 2021
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 769 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Nutricia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jieshu Wu, Ph.D, Principal investigator, Nanjing Medical University Jiangning Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235412
- Sponsor's protocol ID
- SBB20R&32016
- Acronym
- Phoenix
- Status last verified
- Aug 2024
- First submitted
- 10 Dec 2021
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on Milk Composition, Health Outcomes, and Feeding Practices of Chinese Mothers and Infants
- ClinicalTrials.gov ID
- NCT05235412
- Acronym / sponsor ID
- Phoenix / SBB20R&32016
- Conditions
- Breast Feeding, Breast Milk Expression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 769 participants (actual)
- Lead sponsor
- Danone NutriciaIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cohort study to understand the changes of breastmilk composition in the first six months after birth of Chinese infants.
Detailed description
The relationship of breastmilk composition, the maternal gut microbiome and lifestyle factors such as diet, feeding practices and physical activity and the infant's health and gut microbiome will be investigated in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese mothers with the intention to breastfeed, and their infants. | – | Other: Not applicable: Observational study without any interventions.Observational study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Generally healthy mothers with the intention to breastfeed, and their infants.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
- A BMI of <18.5 or ≥ 28 pre-pregnancy or during the first regular pregnancy check around or before 16 weeks of gestational age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable: Observational study without any interventions.Exposures of interest: Maternal diet and lifestyle, demographics, anthropometrics, infant's health outcomes | Other | Chinese mothers with the intention to breastfeed, and their infants. |
Primary outcome
Changes in human milk protein concentration
Time frame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Protein concentration in g/l of human milk will be analyzed
Changes in human milk fat concentration
Time frame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Fat concentration in g/l of human milk will be analyzed
Changes in human milk carbohydrate concentration
Time frame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Carbohydrate concentration in g/l of human milk will be analyzed
Changes in human milk energy content
Time frame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Energy content in kCal/l of human milk will be analyzed
Changes in infant length
Time frame: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Length measured in cm
Changes in infant head circumference
Time frame: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Head circumference measured in cm
Changes in infant weight
Time frame: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Weight measured in grams
10 secondary outcomes
Variations in human milk microbiome
Time frame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Variations in human milk micronutrients
Time frame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Variations in human milk oligosaccharides (HMOs)
Time frame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Variations in human milk lipid composition
Time frame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Variations in human milk amino acids and proteins
Time frame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Variations in infant fecal microbiome
Time frame: Infant fecal samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Variations in maternal fecal microbiome
Time frame: Maternal fecal samples collected at 1 month, 3 month, 6 months, 12 months after infant birth
Changes in infant stool consistency and frequency
Time frame: Data collected at 1 month, 3 month, 6 months, 12 months after infant birth
Changes in infant feeding practices
Time frame: Data collected at 1 month, 3 month, 6 months, 12 months,2 years after infant birth
Changes in maternal body mass index
Time frame: Data collected at 1 month, 3 month, 6 months, 12 months 2 years after infant birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jieshu Wu, Ph.D principal investigator
Nanjing Medical University Jiangning Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Feeding and Breast Milk Expression, run by Danone Nutricia at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in human milk protein concentration (time frame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.