|- candidate number||8451|
|- NTR Number||NTR2523|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-sep-2010|
|- Secondary IDs||SYN.2.C/A Danone Research|
|- Public Title||Effect of synbiotics in infants with atopic dermatitis up to 7 years of life.|
|- Scientific Title||Effect of synbiotics in infants with atopic dermatitis up to 7 years of life.|
|- ACRONYM||SYNBAD Follow Up Study|
|- hypothesis||A positive effect of the study product in preventing asthma like symptoms in infants at high risk for developing asthma later in childhood.|
|- Healt Condition(s) or Problem(s) studied||Allergy, Asthma|
|- 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.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||25-sep-2010|
|- planned closingdate||31-dec-2013|
|- Target number of participants||78|
|- Interventions||Not applicable. This is an observational follow up study that investigates interventions that were done in a previous study.|
|- Primary outcome||Prevalence of asthma, measured by a lungtest & questionnaires.|
|- Secondary outcome||Allergic manifestations, as diagnosed by a physician or by means of questionnaires|
|- Timepoints||The study will last 58 weeks and consists of 4 hospital visits and 3 phone calls.|
|- Trial web site|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. M. Roelofs|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M. Roelofs|
|- Sponsor/Initiator ||Danone Research B.V.|
(Source(s) of Monetary or Material Support)
|Nutricia Research - Centre for Specialised Nutrition |
|- Brief 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.
|- Main changes (audit trail)||31-03-2014: The first subject was included 24Mar2011 and the last subject was out of the study 8Oct2013. Danone Research changed names into Nutricia Research - AB|
|- RECORD||15-sep-2010 - 31-mrt-2014|