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

Recruiting

• Conditions: Breast Feeding; Breast Milk Expression

• Registration Number: NCT05235412
• Lead Sponsor: Danone Nutricia

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.

Study Timeline

• Study Start: 2021-11-19
• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2026-11-30
• Study Completion: 2028-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 750

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 weight	Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth	Weight measured in grams
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 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 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 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

Secondary Outcome Measures

Name	Time	Method
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
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
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
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
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 \[kg/m2\]
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

Trial Locations

Locations (1)

Nanjing Medical University Jiangning Campus; 🇨🇳 Nanjing, Jiangsu, China