Breast Feeding, Milk, Human
Conditions
Keywords
Breast Feeding, Human milk, Research, Lactation, Human Milk Oligosaccharide, HMO
Brief summary
The current longitudinal (max. 2-year) observational cohort study in 120 lactating mothers and their newborns will make it possible to explore human milk composition across different lactation stages, between different human milk groups, and in relation to maternal, perinatal, infant, and sample characteristics as well as to the microbiota of the infant.
Interventions
None listed
Sponsors
Nutricia Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Netherlands
Contacts
Primary ContactDanone Nutricia Research N Research
Outcome results
None listed