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OP PAD Follow up - Primary prevention of atopic disease with prebiotics and the role of the intestinal microflora Follow up.


- candidate number13098
- NTR NumberNTR3505
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jul-2012
- Secondary IDsAll.2.C/A  Danone
- Public TitleOP PAD Follow up - Primary prevention of atopic disease with prebiotics and the role of the intestinal microflora Follow up.
- Scientific TitleObservational, double-blind, controlled follow up study as an extension of a double-blind controlled and randomised study that investigates the effect of partial hydrolysed formula feeding (IF and FOF) supplemented with a mixture of prebiotics in healthy term born infants during their first year of life (during OP PAD) on the prevalence of atopic diseases at 6 years of life.
- ACRONYMOP PAD Follow up
- hypothesisReduced prevalence of atopic diseases in children who were fed prebiotic supplemented formula during the first year of life at 6 years of age.
- Healt Condition(s) or Problem(s) studiedAtopic disease, Risc
- Inclusion criteria1. Children who have completed the OP PAD study;
2. Written informed consent of both patents;
3. Age < 6.5 years.
- Exclusion criteriaInvestigator's uncertainty about the willingness or ability of the subjects to comply with the protocol requirements.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-sep-2010
- planned closingdate1-sep-2012
- Target number of participants97
- InterventionsNA (Follow-up study).
- Primary outcomeThe primary objective of this study is to investigate in initial OP PAD study participants (children, who were at risk of developing atopic disease, and have received (partially or completely) either a partial hydrolysed infant formula supplemented with a prebiotic mixture or a partial hydrolysed infant formula without prebiotics or who were fully breastfed during the first year of life) the prevalence of atopic diseases (atopic dermatitis, allergic asthma) at 6 years of age.
- Secondary outcomeSecondary objective of this study is to investigate in the OP PAD study participants at 6 years of age the following:
1. In case of allergic manifestations the severity of atopic dermatitis and allergic asthma;
2. Allergic rhinitis;
3. Lung function measurements;
4. Immunological Parameters;
5. Intestinal flora.
- TimepointsTime points of the outcome: V0 (screening home visit); V1 (hospital visit; 6- 12 weeks after V0).
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES L. Dumon
- CONTACT for SCIENTIFIC QUERIES L. Dumon
- Sponsor/Initiator Nutricia Research Centre for Specialised Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsN/A
- Brief summaryThe study is a follow up study to investigate whether intervention with prebiotics during the first year of life has an impact on prevalence of atopic diseases at 6 years of age. It is an observational study; based on randomized; controlled, double-blind parallel-group study in the first year of life. The study started in 2010 and is expected to be closed in October 2012.
- Main changes (audit trail)
- RECORD3-jul-2012 - 13-jul-2012


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