Clinical trial NCT05235412: A Cohort Study on Milk Composition, Health Outcomes, and Feeding Practices of Chinese Mothers and Infants
Official title: A Cohort Study on Milk Composition, Health Outcomes, and Feeding Practices of Chinese Mothers and Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Feeding
Breast Milk Expression
Lead sponsor: Danone Nutricia
Sponsor class: INDUSTRY
First posted: 2022-02-11
Enrollment: 750
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Generally healthy mothers with the intention to breastfeed, and their infants.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in human milk protein concentration
timeFrame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
measure: Changes in human milk fat concentration
timeFrame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
measure: Changes in human milk carbohydrate concentration
timeFrame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
measure: Changes in human milk energy content
timeFrame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
measure: Changes in infant length
timeFrame: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
measure: Changes in infant head circumference
timeFrame: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
measure: Changes in infant weight
timeFrame: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Secondary outcomes:
measure: Variations in human milk microbiome
timeFrame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
measure: Variations in human milk micronutrients
timeFrame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
measure: Variations in human milk oligosaccharides (HMOs)
timeFrame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
measure: Variations in human milk lipid composition
timeFrame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
measure: Variations in human milk amino acids and proteins
timeFrame: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
measure: Variations in infant fecal microbiome
timeFrame: Infant fecal samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
measure: Variations in maternal fecal microbiome
timeFrame: Maternal fecal samples collected at 1 month, 3 month, 6 months, 12 months after infant birth
measure: Changes in infant stool consistency and frequency
timeFrame: Data collected at 1 month, 3 month, 6 months, 12 months after infant birth
measure: Changes in infant feeding practices
timeFrame: Data collected at 1 month, 3 month, 6 months, 12 months,2 years after infant birth
measure: Changes in maternal body mass index
timeFrame: Data collected at 1 month, 3 month, 6 months, 12 months 2 years after infant birth
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Medical University Jiangning Campus
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University Jiangning Campus
name: Jieshu Wu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: