Analyzing the Composition of Human Milk in Lactating Mothers and Their Newborns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study will follow 120 lactating mothers and their newborns over a maximum of two years to investigate the composition of human milk at various stages of lactation. The study aims to explore differences in milk composition based on maternal, perinatal, and infant characteristics, as well as the microbiota of the infant. Participants will provide residual human milk samples for analysis, contributing to a better understanding of breastfeeding and human milk's role in infant health.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pregnant women in the third trimester of pregnancy (≥28 weeks) who have the intention to provide breastfeeding for at least 6 months post-partum.
* Age ≥ 18 years.
* Willingness to provide residual human milk.
* Living in proximity of NCRU (clinical site in NL).
* Dutch speaking and reading.
* Freezer -18°C available.
* Having mobile phone, tablet, or computer available.
* Signed informed consent from the subject (pregnant woman).
* Signed informed consent from the other parent and/or legally acceptable representative, of the unborn baby(s), aged ≥ 18 years.

Exclusion Criteria:

* Pregnant women known positive for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).
* Multiple pregnancy \> 2.
* Incapability of subjects to comply with study protocol as per the judgment of the site staff (e.g. fluency in local language, access to laptop/smartphone devices and internet connection required for data collection).
* Women (and their unborn baby(s)) with current or intended participation in any other clinical study involving investigational or marketed products.
* Employees and/or children/family members or relatives of employees of Nutricia Research or the participating site.

Continuation exclusion criteria (after birth)

* Stillbirth
* Newborn having any congenital abnormality, chromosomal disorder or severe disease that would prevent the infant from breastfeeding and/or growing normally based on the opinion of a health care professional and/or study physician.
* No donation of any milk sample within the first 8 weeks postpartum (timepoints week 1, week 1.5, and week 4).

Where it's running

• Danone Nutricia Research
  Utrecht, Netherlands Recruiting

Study contacts

• Study coordinator: Danone Nutricia Research N Research
• Email: register.clinicalresearchnutricia@danone.com
• Phone: +31 30 2095 000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.