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

Breast Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05979532
• Other study ID #: SBB21R&35943
• Status: Recruiting
• Start date: February 13, 2024
• Est. completion date: August 31, 2027

Study information

• Verified date: March 2024
• Source: Nutricia Research
• Contact: Danone Nutricia Research N Research
• Phone: +31 30 2095 000
• Email: register.clinicalresearchnutricia[@]danone.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Feeding
• Milk, Human

Locations

Country	Name	City	State
Netherlands	Danone Nutricia Research	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.
Primary	The following exploratory faecal outcome parameter will be analysed if sufficient faecal samples are collected.	Laboratory analyses of Infant's faecal microbiome composition.	at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.