No registrations found.
ID
Source
Brief title
Health condition
Asthma & allergies
Sponsors and support
Intervention
Outcome measures
Primary outcome
Prevalence of asthma, measured by a lungtest & questionnaires.
Secondary outcome
Allergic manifestations, as diagnosed by a physician or by means of questionnaires
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, 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 accepted for publication).
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
A positive effect of the study product in preventing asthma like symptoms in infants at high risk for developing asthma later in childhood.
Study design
The study will last 58 weeks and consists of 4 hospital visits and 3 phone calls.
Intervention
Not applicable. This is an observational follow up study that investigates interventions that were done in a previous study.
P.O. Box 7005
M. Roelofs
Wageningen 6700 CA
The Netherlands
+31 (0)317 467800
mieke.roelofs@danone.com
P.O. Box 7005
M. Roelofs
Wageningen 6700 CA
The Netherlands
+31 (0)317 467800
mieke.roelofs@danone.com
Inclusion criteria
1. Participation and completion of Synbad study (all PP subjects);
2. Between 5 years and 6 months and 6 years of age;
3. 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 |
|---|---|
| NTR-new | NL2415 |
| NTR-old | NTR2523 |
| Other | Danone Research : SYN.2.C/A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |