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Tolerance of probiotics in the neonate.


- candidate number1663
- NTR NumberNTR313
- ISRCTNISRCTN78225533
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR15-sep-2005
- Secondary IDsN/A 
- Public TitleTolerance of probiotics in the neonate.
- Scientific TitleTolerance for probiotics and its effect on growth and feces of neonates.
- ACRONYMPINGO (Probiotica in Neonatale Groei en Ontlasting)
- hypothesisProbiotics are tolerated well by infants (age 0-3 months) and results in a microbial flora resembling that of breastfed infants.
- Healt Condition(s) or Problem(s) studiedNo condition, healthy person
- Inclusion criteria1. Healthy, term neonate;
2. Age < 7 days;
3. Informed consent;
4. Parents are fluent in Dutch.
- Exclusion criteria1. Antibiotics postpartum;
2. Congenital malformations etc.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-nov-2004
- planned closingdate1-jan-2007
- Target number of participants150
- InterventionsAll infants receive formula feeding for the first three months, 75 with probiotics (L. casei and B. animalis) and 75 without.
- Primary outcomeGrowth parameters.
- Secondary outcomeGutflora (tested with quantative PCR) hours of crying, sleeping etc defecation patterns.
- Timepoints
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. Arine M. Vlieger
- CONTACT for SCIENTIFIC QUERIESDrs. Arine M. Vlieger
- Sponsor/Initiator Friesland Foods
- Funding
(Source(s) of Monetary or Material Support)
Friesland coberco dairy foods, Friesland Nutrion research
- PublicationsN/A
- Brief summaryThis randomized controlled trial in 150 infants age 0 to 3 months studies the tolerance and effect of two probiotics in formula feeding on growth and gut flora. The safety of these probiotics is tested through growth parameters (weight, lenght and head circumference) and the monitoring of side-effects. Secondary outcomes are the effect of probiotics on the number of probiotics in the feces and on quality of life.
- Main changes (audit trail)
- RECORD15-sep-2005 - 4-nov-2009


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