NCT05979532 A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk
| NCT ID | NCT05979532 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nutricia Research |
| Condition | Breast Feeding |
| Study Type | OBSERVATIONAL |
| Enrollment | 172 participants |
| Start Date | 2024-02-13 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 172 participants in total. It began in 2024-02-13 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Danone Nutricia Research N Research
✉ register.clinicalresearchnutricia@danone.com📞 +31 30 2095 000
Frequently Asked Questions
Who can join the NCT05979532 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Feeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05979532 currently recruiting?
Yes, NCT05979532 is actively recruiting participants. Contact the research team at register.clinicalresearchnutricia@danone.com for enrollment information.
Where is the NCT05979532 trial being conducted?
This trial is being conducted at Utrecht, Netherlands.
Who is sponsoring the NCT05979532 clinical trial?
NCT05979532 is sponsored by Nutricia Research. The trial plans to enroll 172 participants.