A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk

Primary outcomes

• Examples of exploratory outcome parameters in this study are the following human milk outcome parameters. [at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.]: Laboratory analyses of Human Milk Oligosaccharides (HMOs), proteins, amino acids, lipids, and fatty acids.
• The following exploratory faecal outcome parameter will be analysed if sufficient faecal samples are collected. [at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.]: Laboratory analyses of Infant's faecal microbiome composition.

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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).