An observational study in Breast Feeding and Breast Milk Expression, sponsored by Danone Nutricia. Completed at 1 site in China. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Danone Nutricia (part of Danone) · Observational
This is a cohort study to understand the changes of breastmilk composition in the first six months after birth of Chinese infants.
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.
88 studies on the registry are indexed under Breast Milk Expression; 20 are open to participants now.
This study's enrollment of 769 is above the median of 71 across 36 observational studies indexed under Breast Milk Expression.
Browse Breast Milk Expression studies →Danone Nutricia is the lead sponsor of 8 studies on the registry; none are open to participants now.
Compared within Breast Milk Expression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Breast Feeding. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Generally healthy mothers with the intention to breastfeed, and their infants.
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.
Mothers:
Infants:
Exclusion Criteria:
Mothers:
Infants:
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.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Observational study.
Other: Not applicable: Observational study without any interventions.
Exposures of interest: Maternal diet and lifestyle, demographics, anthropometrics, infant's health outcomes
Changes in human milk protein concentration
Protein concentration in g/l of human milk will be analyzed
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Variations in human milk microbiome
Analyzed by sequencing
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
Analyzed by mass spectrometry
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)
Analyzed by mass spectrometry
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
Analyzed by mass spectrometry
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
Analyzed by mass spectrometry
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
Analyzed by sequencing
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
Analyzed by sequencing
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
Data will be collected via diaries using the Brussel Infant and Toddler Stool Scale
Time frame: 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
Time frame: 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 \[kg/m2\]
Time frame: Data collected at 1 month, 3 month, 6 months, 12 months 2 years after infant birth
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2021 to primary completion in Jul 2025, 44 months.
Of 25 observational studies under Breast Milk Expression, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 44. This study's 44 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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