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Primairy prevention of atopic disease by perinatal administration of probiotics.


- candidate number1523
- NTR NumberNTR323
- ISRCTNISRCTN52995544
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsN/A 
- Public TitlePrimairy prevention of atopic disease by perinatal administration of probiotics.
- Scientific TitlePrimairy prevention of atopic disease by perinatal administration of probiotics.
- ACRONYMPANDA
- hypothesisAdministration of probiotics to pregnant women from an atopic family and subsequently to their high-risk newborns results in prevention of the incidence of or in a decrease of the severity of atopic disease during infancy.
- Healt Condition(s) or Problem(s) studiedPregnancy, Allergy, Atopic disease
- Inclusion criteriaPregnant mothers were included if either they themselves or their husband plus a sibling suffered from present or past atopic disease.
- Exclusion criteria1. Maternal use of immunomodulatory drugs during pregnancy; 2. The use of probiotics.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-2004
- planned closingdate1-jan-2009
- Target number of participants120
- InterventionsA combination of probiotics (Lact.Lactis, B.Bifidum, B.Infantum), each 1000 milion daily, added to the the formula used.
- Primary outcomeIncidence and severity of atopic disease at the age of 2 years.
- Secondary outcome1. SCORAD;
2. Lung function;
3. Serum IgE (Total and specific);
4. Cytokines produced by peripheral blood derived mononuclear cells;
5. Bacterial content of stools during the first weeks of life.
- Timepoints
- Trial web sitehttp://www.kinderallergologie.nl choose: website PANDA-onderzoek
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M.O. Hoekstra
- CONTACT for SCIENTIFIC QUERIESDr. M.O. Hoekstra
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital (WKZ)
- Funding
(Source(s) of Monetary or Material Support)
Wilhelmina Children's Hospital research fund
- PublicationsN/A
- Brief summaryInclusion of pregnant mothers from atopic families has ended. Around January first 2006 all children are born. Results on cord blood analysis are expected in spring of 2006. Clinicial data at the age of 3 months are expected just before the summer of 2006.
- Main changes (audit trail)
- RECORD9-sep-2005 - 7-mrt-2006


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