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

Last updated: August 27, 2024
Sponsor: Danone Nutricia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Feeding

Treatment

Not applicable: Observational study without any interventions.

Clinical Study ID

NCT05235412
SBB20R&32016
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 milkformula, at enrolment.

  3. Chinese ethnicity of mother and father.

Exclusion

Exclusion Criteria:

Mothers:

  1. Participation in any other studies involving investigational or marketed productsconcomitantly 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 outof the current city; incapability of mothers to comply with study protocol orinvestigator' s uncertainty about the willingness or ability of the mothers tounderstand and comply with the protocol requirements.

  3. Illegal drug use.

  4. Regular smoking and/ or consumption of alcoholic beverages as per investigator'sjudgement.

  5. A BMI of <18.5 or ≥ 28 pre-pregnancy or during the first regular pregnancy checkaround or before 16 weeks of gestational age.

  6. Acute infectious disease or neoplastic disease or any kind of weakening ordebilitating conditions (with history of positive, hepatitis C virus (HCV) or HIVserological test at any time during the pregnancy).

  7. Presence of mastitis, fungal infections of the nipple or areola; reactivation ofherpes simplex (HSV) or varicella zoster infection in the mammary or thoracic regionat the time of enrolment.

  8. Presence of chronic diseases such as endocrine, cardiovascular, renal, respiratoryor hepatic diseases.

  9. Presence of psychosis and severe post-partum depression.

  10. Presence of autoimmune disease such as systemic lupus erythematosus, systemicscleroderma, ulcerative colitis, Crohn's disease, celiac disease.

  11. Women whose health condition, according to the investigator's judgement, couldinterfere with the study conduction and assessment.

  12. Mothers who have given birth to twins or multiples or infant conceived with AssistedReproductive Technology (ART).

Infants:

  1. Participation in any other studies involving investigational or marketed productsconcomitantly or two weeks prior to entry into the study.

  2. At enrolment, any congenital abnormality, chromosomal disorder or severe diseasewhich 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

Total Participants: 750
Treatment Group(s): 1
Primary Treatment: Not applicable: Observational study without any interventions.
Phase:
Study Start date:
November 19, 2021
Estimated Completion Date:
March 30, 2028

Study 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.

Connect with a study center

  • Nanjing Medical University Jiangning Campus

    Nanjing, Jiangsu 211166
    China

    Active - Recruiting

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