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

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

Detailed Description
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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.

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

Conditions
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Breast Feeding, Breast Milk Expression

Intervention / Treatment
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* Other: Not applicable: Observational study without any interventions.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chinese mothers with the intention to breastfeed, and their infants.<br>Observational study. | Other: Not applicable: Observational study without any interventions.<br>* Exposures of interest: Maternal diet and lifestyle, demographics, anthropometrics, infant's health outcomes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in human milk protein concentration | Protein concentration in g/l of human milk will be analyzed | Human milk samples collected at 1 month, 3 month, 6 months, 12 months after infant birth | 
| Changes in human milk fat concentration | Fat concentration in g/l of human milk will be analyzed | Human milk samples collected at 1 month, 3 month, 6 months, 12 months after infant birth | 
| Changes in human milk carbohydrate concentration | Carbohydrate concentration in g/l of human milk will be analyzed | Human milk samples collected at 1 month, 3 month, 6 months, 12 months after infant birth | 
| Changes in human milk energy content | Energy content in kCal/l of human milk will be analyzed | Human milk samples collected at 1 month, 3 month, 6 months, 12 months after infant birth | 
| Changes in infant length | Length measured in cm | Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months after infant birth | 
| Changes in infant head circumference | Head circumference measured in cm | Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months after infant birth | 
| Changes in infant weight | Weight measured in grams | Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months after infant birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variations in human milk microbiome | Analyzed by sequencing | Human milk samples collected at 1 month, 3 month, 6 months, 12 months after infant birth | 
| Variations in human milk micronutrients | Analyzed by mass spectrometry | Human milk samples collected at 1 month, 3 month, 6 months, 12 months after infant birth | 
| Variations in human milk oligosaccharides (HMOs) | Analyzed by mass spectrometry | Human milk samples collected at 1 month, 3 month, 6 months, 12 months after infant birth | 
| Variations in human milk lipid composition | Analyzed by mass spectrometry | Human milk samples collected at 1 month, 3 month, 6 months, 12 months after infant birth | 
| Variations in human milk amino acids and proteins | Analyzed by mass spectrometry | Human milk samples collected at 1 month, 3 month, 6 months, 12 months after infant birth | 
| Variations in infant fecal microbiome | Analyzed by sequencing | Infant fecal samples collected at 1 month, 3 month, 6 months, 12 months after infant birth | 
| Variations in maternal fecal microbiome | Analyzed by sequencing | 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 | 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 | Data collected at 1 month, 3 month, 6 months, 12 months after infant birth | 
| Changes in maternal body mass index | Maternal weight and height will be combined to determine body mass index [kg/m2] | Data collected at 1 month, 3 month, 6 months, 12 months after infant birth |