Defining which sampling site in the mouth in infants and their mothers is most reproducible as determined by the differences in microbiota composition of samples collected by a trained researcher and those collected by the mother
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
er wordt geen aandoening onderzocht
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint will be reproducibility of sampling oral sites as determined
by the differences in microbiota composition of samples collected by a trained
researcher and those collected by the mother.
Secondary outcome
Information about the feasibility such as comprehensibility of the instruction
video and sampling site will be collected.
Background summary
It is becoming more and more apparent that human microbiota influences health
and disease. The oral microbiota develops during the first three years after
birth, but it remains unclear what factors drive this development. Studying the
oral microbiota can provide us with valuable insights in its influence on human
health. Especially large scale longitudinal studies are needed to gain
knowledge on this subject. Home sampling would make studying of the oral
microbiota less costly and more convenient for the study subjects in these kind
of studies. Although several oral sites can be used for home sampling,
information on reproducibility is lacking. Besides, little is known about
feasibility of oral sampling in infants. This study aims to evaluate
reproducibility and feasibility of several oral sampling sites.
Study objective
Defining which sampling site in the mouth in infants and their mothers is most
reproducible as determined by the differences in microbiota composition of
samples collected by a trained researcher and those collected by the mother
Study design
Observational study design
Study burden and risks
Development of oral microbiota can only be studied in infants, since oral
microbiota develops in the first 3 years after birth. This study is therefore
group-related. The burden of taking oral microbiota samples is very low and the
methods are non-invasive, so the risk of participating in the study is limited
for the infants and their mothers. By participating in this study, mothers gain
information on oral care for their infants, and receive a free toothbrush. We
expect no adverse or serious adverse events of this non-invasive data
collection. 7-9 samples will be collected per infant and mother.
Gustav Mahlerlaan 3004
Amsterdam 1081LA
NL
Gustav Mahlerlaan 3004
Amsterdam 1081LA
NL
Listed location countries
Age
Inclusion criteria
For mothers: Having an infant aged 2-4; 6-8 or 12-14 months
For infants: Being an infant aged 2-4; 6-8 or 12-14 months
Exclusion criteria
Not mastering the Dutch language
Mothers younger than 18 years old
Serious congenital abnormalities
Guardian not available for consent
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 | NL66102.018.18 |