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

Recruiting

• Conditions: Breast Feeding; Milk, Human

• Registration Number: NCT05979532
• Lead Sponsor: Nutricia Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-07
• Study Start: 2024-02-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 172

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Danone Nutricia Research; 🇳🇱 Utrecht, Netherlands