A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk (White Gold)

March 14, 2024 updated by: Nutricia Research

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

172

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examples of exploratory outcome parameters in this study are the following human milk outcome parameters.
Time Frame: 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.
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.
Time Frame: at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.
Laboratory analyses of Infant's faecal microbiome composition.
at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutricia Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2024

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SBB21R&35943

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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