The objective of this study is to further unravel the complexity of human milk and its variations over lactation stages and between individuals.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
studie met gezonde vrijwilligers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome parameters:
Examples of the exploratory outcome parameters in this study are the following
human milk outcome parameters at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104:
* Proteins
* Amino acids
* Lipids
* Fatty acids
The following exploratory faecal outcome parameter at Day 3 and at Week 1.5, 4,
10, 26, 52, and 104 will be analysed if sufficient faecal samples are collected:
* Infant*s faecal microbiome composition
Secondary outcome
Not applicable.
Background summary
The current observational cohort study design will make it possible to explore
human milk composition and functionality and 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.
The proposed timepoints at which human milk samples (and optionally faecal
samples) will be collected cover all different lactation stages:
* Colostrum (first [1-5] days postpartum)
* Transitional milk (1.5 weeks postpartum; preferred time window: 6-15 days
postpartum)
* Early to mature milk (4 weeks postpartum; preferred time window: 3-8 weeks
postpartum)
* Mature milk before weaning (10 weeks postpartum; preferred time window: 9-12
weeks postpartum)
* Mature milk after weaning (26±2 weeks postpartum)
Furthermore, the following additional timepoints are included because the
majority of current research lack data from the period after 6 months
postpartum:
* Mature milk (52±2 weeks postpartum)
* Mature milk (104±2 weeks postpartum)
The current study will be conducted in The Netherlands, in an area in proximity
of Danone Nutricia Research Utrecht. The collected human milk samples and
infants* faecal samples will be shipped to and processed by Nutricia Research
laboratories in Utrecht, The Netherlands.
Study objective
The objective of this study is to further unravel the complexity of human milk
and its variations over lactation stages and between individuals.
Study design
A longitudinal prospective, observational, single-centre, exploratory, cohort
study
Study burden and risks
Subjects will be asked to complete an initial digital questionnaire after
signing informed consent. Then, at 7 time points spread over 2 years, subjects
will be asked to complete a digital questionnaire, collect breast milk
sample(s) and an optional fecal sample from the infant. The lab samples will be
collected from the subject's home by a courier. At an end of the study, the
subject will be asked to complete a final evaluation.
The burden for participants in this study is considered small. Subject
participation contributes to gaining more knowledge about the composition and
functionality of breast milk and improving nutrition for infants and young
children; this outweighs the low burden.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
1. Pregnant women in the third trimester of pregnancy (>=28 weeks) who have the
intention to provide breastfeeding for at least 6 months post-partum
2. Age >= 18 years
3. Willingness to provide residual human milk
4. Located in proximity of NCRU
5. Dutch speaking and reading
6. Freezer -18°C available
7. Having mobile phone, tablet, or computer available
8. Signed informed consent from subject (pregnant woman)
9. Signed informed consent from the other parent and/or legally acceptable
representative of the unborn baby(s), aged >= 18 years.
Exclusion criteria
1. Pregnant women known positive for human immunodeficiency virus (HIV),
hepatitis B (HBV) or hepatitis C (HCV) (self-reported). 2. Multiple pregnancy
(more than 2). 3. Incapability of subjects to comply with study protocol as per
the judgment of the study staff (e.g. fluency in local language, access to
laptop/smartphone devices and internet connection required for data
collection). 4. Women (and their unborn baby(s)) with current or intended
participation in any other clinical study involving investigational or marketed
products. 5. Employees and/or children/family members or relatives of employees
of Nutricia Research or the participating site. After enrolment the following
continuation criteria will lead to discontinuation of the study. 1. Still
birth. 2. Newborn having any congenital abnormality, chromosomal disorder or
severe disease that would prevent the infant from breastfeeding and growing
normally based on the opinion of a health care professional and/or study
physician. 3. No donation of any milk sample within the first 8 weeks
postpartum (timepoints week 1, week 1.5, and week 4).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84310.056.23 |