A longitudinal prospective, observational, cohort study in lactating mothers and their newborns to further unravel the complexity of human milk

A longitudinal prospective, observational, cohort study in lactating mothers and their newborns to further unravel the complexity of human milk - White Gold

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53220

Enrollment

140

Registered

2023-05-17

Start date

2024-02-13

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Not applicable

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Pregnant women in the third trimester of pregnancy (>=28 weeks) who have the intention to provide breastfeeding for at least 6 months post-partum 2. Age >= 18 years 3. Willingness to provide residual human milk 4. Located in proximity of NCRU 5. Dutch speaking and reading 6. Freezer -18°C available 7. Having mobile phone, tablet, or computer available 8. Signed informed consent from subject (pregnant woman) 9. Signed informed consent from the other parent and/or legally acceptable representative of the unborn baby(s), aged >= 18 years.

Exclusion criteria

Exclusion criteria: 1. Pregnant women known positive for human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) (self-reported). 2. Multiple pregnancy (more than 2). 3. Incapability of subjects to comply with study protocol as per the judgment of the study staff (e.g. fluency in local language, access to laptop/smartphone devices and internet connection required for data collection). 4. Women (and their unborn baby(s)) with current or intended participation in any other clinical study involving investigational or marketed products. 5. Employees and/or children/family members or relatives of employees of Nutricia Research or the participating site. After enrolment the following continuation criteria will lead to discontinuation of the study. 1. Still birth. 2. Newborn having any congenital abnormality, chromosomal disorder or severe disease that would prevent the infant from breastfeeding and growing normally based on the opinion of a health care professional and/or study physician. 3. No donation of any milk sample within the first 8 weeks postpartum (timepoints week 1, week 1.5, and week 4).

Design outcomes

Primary

Measure	Time frame
Outcome parameters: Examples of the 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: * Proteins * Amino acids * Lipids * Fatty acids The following exploratory faecal outcome parameter at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 will be analysed if sufficient faecal samples are collected: * Infant*s faecal microbiome composition	—

Measure

Time frame

Outcome parameters: Examples of the 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: * Proteins * Amino acids * Lipids * Fatty acids The following exploratory faecal outcome parameter at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 will be analysed if sufficient faecal samples are collected: * Infant*s faecal microbiome composition

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Contacts

Public ContactETHC Smeets

Danone Global research & Innovation center

ellen.smeets@danone.com0641492556

Outcome results