Analyzing the Composition of Human Milk in Lactating Mothers and Their Newborns

A Longitudinal Prospective, Observational, Cohort Study in Lactating Mothers and Their Newborns to Further Unravel the Complexity of Human Milk

This study looks at the different ingredients in breast milk from new mothers and how they change over time to see how they affect the health of their babies.

Quick facts

• Study type: Observational
• Enrollment: 172 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Nutricia Research (industry)
• Locations: 1 site (Utrecht)
• Trial ID: NCT05979532 on ClinicalTrials.gov

What this trial studies

This observational cohort study will follow 120 lactating mothers and their newborns over a maximum of two years to investigate the composition of human milk at various stages of lactation. The study aims to explore differences in milk composition based on maternal, perinatal, and infant characteristics, as well as the microbiota of the infant. Participants will provide residual human milk samples for analysis, contributing to a better understanding of breastfeeding and human milk's role in infant health.

Who should consider this trial

Good fit: Ideal candidates are pregnant women in their third trimester who plan to breastfeed for at least six months and meet specific eligibility criteria.

Not a fit: Patients who are HIV, HBV, or HCV positive, or those with multiple pregnancies, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance knowledge about human milk composition, potentially leading to improved breastfeeding practices and infant nutrition.

How similar studies have performed: While similar studies have been conducted, this specific approach focusing on longitudinal analysis of human milk composition is relatively novel.

Eligibility criteria

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).

Where this trial is running

Utrecht

• Danone Nutricia Research — Utrecht, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Danone Nutricia Research N Research

Conditions: Breast Feeding, Milk, Human, Human milk, Research, Lactation, Human Milk Oligosaccharide, HMO