A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNutricia Research
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
120 Lactating mothers who have the intention to breastfeed for at least 6 months and their newborns.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Examples of exploratory outcome parameters in this study are the following human milk outcome parameters.
Laboratory analyses of Human Milk Oligosaccharides (HMOs), proteins, amino acids, lipids, and fatty acids.
Time frame
at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.2
The following exploratory faecal outcome parameter will be analysed if sufficient faecal samples are collected.
Laboratory analyses of Infant's faecal microbiome composition.
Time frame
at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov