Primary study objectiveTo investigate the prevalence of asthma in children up to 7 years of age with atopic dermatitis in infancy who received either Nutrilon Pepti with synbiotics or Nutrilon Pepti without synbiotics during 12 weeks in their first…
ID
Source
Brief title
Condition
- Allergic conditions
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter of this study is the physician*s diagnosed asthma
and controllability (GINA classification) at the age up to 7 years.
Secondary outcome
- Allergic manifestations: diagnosed by physician or by means of questionnaires
(ISAAC derived), including severity (if available)
- Blood analysis (Ig's, cytokines)
- Fecal parameters (bacterial content, PH)
- Anthropometry
- Molecular pattern recognition by smell prints of exhaled volatile organic
compounds (Electronic Nose®)
Background summary
Since atopic dermatitis (AD) is often the starting point of the "allergic
march" and children with AD have a 40% chance of developing asthma later in
life, it is interesting to explore if certain probiotic strains can bring the
allergic march to a halt,and prevent the development of asthma in these
children.
The original Synbad Study showed that the infants with AD who received
synbiotics have a lower prevalence of asthma-like symptoms and asthma
medication use at one-year follow-up than those who received placebo (van der
Aa, Allergy 2010).
Since this study showed a positive effect in preventing asthma like symptoms in
infants at high risk for developing asthma later in childhood, this follow-up
study is a good opportunity for further exploration of the prevalence of
established asthma in the Synbad children up to 7 years of age.
This study is an observational study in which the same groups will be analysed
as in the original double blind parallel randomised SYNBAD trial. For the
participants, the study will last 58 weeks and consists of 4 hospital visits
and 3 phone calls.
Study objective
Primary study objective
To investigate the prevalence of asthma in children up to 7 years of age with
atopic dermatitis in infancy who received either Nutrilon Pepti with synbiotics
or Nutrilon Pepti without synbiotics during 12 weeks in their first 7 months of
life.
Secondary study objective(s)
To investigate the prevalence of allergic manifestations (atopic dermatitis,
allergic rhinitis, allergic conjunctivitis, allergic urticaria and food
allergy) in children up to 7 years of age with atopic dermatitis in infancy and
who received either Nutrilon Pepti with synbiotics or Nutrilon Pepti without
synbiotics during 12 weeks in their first 7 months of life. Furthermore, blood
parameters (e.g. Ig*s, cytokines), fecal parameters (e.g. bacterial
composition, pH) are determined as well.
Study design
Prospective follow-up study (investigator and laboratory technicians are
blinded for treatment groups), following a randomised, controlled, double
blind, parallel design.
Study burden and risks
Based on current information, no negative consequences are expected from
participating in this study.
Postbus 7005
6700 CA Wageningen
NL
Postbus 7005
6700 CA Wageningen
NL
Listed location countries
Age
Inclusion criteria
- Participation to and completion of the Synbad study
- Between 5 years and 6 months and 6 years of age
- Written informed consent from parents/caregivers/legal representatives
Exclusion criteria
Investigator's uncertainty about the willingness or ability of the family to comply with the
protocol requirements
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 | NL33703.018.10 |