Breast Feeding, Breast Milk Expression
Conditions
Brief summary
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.
Interventions
OTHERNot applicable: Observational study without any interventions.
Exposures of interest: Maternal diet and lifestyle, demographics, anthropometrics, infant's health outcomes
Sponsors
Danone Nutricia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in human milk protein concentration | 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 | 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 | 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 | 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 | 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 | 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 | Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth | Weight measured in grams |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variations in human milk microbiome | Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth | Analyzed by sequencing |
| Variations in human milk micronutrients | Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth | Analyzed by mass spectrometry |
| Variations in human milk oligosaccharides (HMOs) | Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth | Analyzed by mass spectrometry |
| Variations in human milk lipid composition | Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth | Analyzed by mass spectrometry |
| Variations in human milk amino acids and proteins | Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth | Analyzed by mass spectrometry |
| Variations in infant fecal microbiome | Infant fecal samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth | Analyzed by sequencing |
| Variations in maternal fecal microbiome | Maternal fecal samples collected at 1 month, 3 month, 6 months, 12 months after infant birth | Analyzed by sequencing |
| Changes in infant stool consistency and frequency | Data collected at 1 month, 3 month, 6 months, 12 months after infant birth | Data will be collected via diaries using the Brussel Infant and Toddler Stool Scale |
| Changes in infant feeding practices | Data collected at 1 month, 3 month, 6 months, 12 months,2 years after infant birth | Dietary data will be collected via questionnaires |
| Changes in maternal body mass index | Data collected at 1 month, 3 month, 6 months, 12 months 2 years after infant birth | Maternal weight and height will be combined to determine body mass index \[kg/m2\] |
Countries
China
Outcome results
None listed