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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Feeding; Breast Milk Expression
• Intervention / Treatment: Other: Not applicable: Observational study without any interventions.

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 Type: Observational
• Enrollment (Anticipated): 750

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 211166
      • Recruiting
      • Nanjing Medical University Jiangning Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chinese mothers with the intention to breastfeed, and their infants.; Observational study.	Other: Not applicable: Observational study without any interventions.; Exposures of interest: Maternal diet and lifestyle, demographics, anthropometrics, infant's health outcomes

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Danone Nutricia

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Anticipated): November 30, 2024
• Study Completion (Anticipated): March 30, 2025

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SBB20R&32016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No