Actively Recruiting
A Longitudinal Observational Study in Lactating Mothers and Their Newborns to Explore Human Milk Composition
Led by Nutricia Research · Updated on 2024-03-15
172
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a longitudinal observational study involving 120 lactating mothers and their newborns to analyze the composition of human milk over different stages of lactation. The study aims to explore variations in milk composition across different milk groups and relate these findings to maternal, perinatal, infant factors, and the infant's microbiota. This research is sponsored by Nutricia Research and spans up to two years of follow-up. Participants will be observed without any intervention, with human milk and fecal samples collected at specific time points: Day 3 and Weeks 1.5, 4, 10, 26, 52, and 104 postpartum. The study focuses on exploratory outcome parameters related to human milk and fecal composition. Mothers will provide residual milk samples during these intervals, which will be analyzed to understand milk complexity. During the study, participants will provide milk and fecal samples at scheduled postpartum visits. Researchers will assess milk composition and infant microbiota through these samples and evaluate the relation to various maternal and infant characteristics. Mothers will need to have access to a freezer at -18°C and use a mobile device for data collection. The total participation duration can be up to two years, allowing detailed monitoring of milk and infant development.
CONDITIONS
Brief Title
A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women in the third trimester (28 weeks or more) who intend to breastfeed for at least 6 months postpartum
- Age 18 years or older
- Willing to provide residual human milk samples
- Living near the study site (NCRU in the Netherlands)
- Able to speak and read Dutch
- Have a freezer available at -18°C
- Have access to a mobile phone, tablet, or computer
- Signed informed consent from the participant (pregnant woman)
- Signed informed consent from the other parent or legal representative of the unborn baby aged 18 years or older
You will not qualify if you...
- Pregnant women positive for HIV, hepatitis B, or hepatitis C
- Multiple pregnancy with more than two babies
- Inability to follow study protocol (e.g., lack of language fluency or device/internet access)
- Current or planned participation in other clinical studies involving investigational or marketed products
- Employees or family members of employees of Nutricia Research or the study site
- Stillbirth after birth
- Newborns with congenital abnormalities, chromosomal disorders, or severe diseases preventing breastfeeding or normal growth
- No milk sample donation within the first 8 weeks postpartum (weeks 1, 1.5, and 4)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years postpartum
Participants provide human milk and fecal samples at multiple postpartum timepoints to analyze the composition of human milk and related parameters.
Visits at Day 3 and at Weeks 1.5, 4, 10, 26, 52, and 104 postpartum
Trial Site Locations
Total: 1 location
1
Danone Nutricia Research
Utrecht, Netherlands, 3584CT
Actively Recruiting
Research Team
D
Danone Nutricia Research N Research
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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