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

NCT05979532 | Recruiting

• 1 other identifier: SBB21R&35943
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Feeding; Milk, Human

Keywords

Breast Feeding; Human milk; Research; Lactation; Human Milk Oligosaccharide; HMO

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study population consists of lactating mothers and their newborn.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

120 Lactating mothers who have the intention to breastfeed for at least 6 months and their newborns.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (1)

Danone Nutricia Research

Utrecht, 3584CT, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The samples may be used in future genetic research. Future genetic research on the samples will only be done when the subject has given a separate consent for this.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

Danone Nutricia Research N Research

CONTACT

+31 30 2095 000; register.clinicalresearchnutricia@danone.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 7, 2023
• Study Start: February 13, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)