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

NCT05235412 | Completed

• 1 other identifier: SBB20R&32016
• Study Type: observational
• Target: 769
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Feeding; Breast Milk Expression

Outcome Measures

Primary Outcomes (7)

• 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, 2 years 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, 2 years 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, 2 years 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, 2 years after infant birth

• Changes in infant length

  Length measured in cm

  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

  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

  Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Secondary Outcomes (10)

• Variations in human milk microbiome

  Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

• Variations in human milk micronutrients

  Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

• Variations in human milk oligosaccharides (HMOs)

  Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

• Variations in human milk lipid composition

  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

  Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Study Arms (1)

Chinese mothers with the intention to breastfeed, and their infants.

Observational study.

Other: Not applicable: Observational study without any interventions.

Interventions

Not applicable: Observational study without any interventions. OTHER

Exposures of interest: Maternal diet and lifestyle, demographics, anthropometrics, infant's health outcomes

Chinese mothers with the intention to breastfeed, and their infants.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Generally healthy mothers with the intention to breastfeed, and their infants.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danone Nutricia: lead

Study Sites (1)

Nanjing Medical University Jiangning Campus

Nanjing, Jiangsu, 211166, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool, human milk, saliva

MeSH Terms

Conditions

Breast Feeding; Breast Milk Expression

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Jieshu Wu, Ph.D

  Nanjing Medical University Jiangning Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: February 11, 2022
• Study Start: November 19, 2021
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 5, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)