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The effects of a prebiotic supplement of fecal consistancy, mineral absorption and gut flora in low birthweight infants.


- candidate number1517
- NTR NumberNTR315
- ISRCTNISRCTN87058658
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsN/A 
- Public TitleThe effects of a prebiotic supplement of fecal consistancy, mineral absorption and gut flora in low birthweight infants.
- Scientific TitleThe effects of a prebiotic supplement of fecal consistancy, mineral absorption and gut flora in low birthweight infants.
- ACRONYMPOEMA trial
- hypothesisPrebiotics are present in breastfeeding and thusfar not in premture formula, we presume that adding prebiotics to premature formula, will be well tolarated, result in more loose stools compared to regular premature formula and will be responsable for gut flora which is present in breastfed infants.
- Healt Condition(s) or Problem(s) studiedPreterm neonates, Low birth weight infants, Premature infants
- Inclusion criteria1. Gestational age less then 34 weeks;
2. Birthweight less then 1700 grams.
- Exclusion criteria1. Congenital defects;
2. Motility disorders of the gut;
3. Necrotising enterocolitis;
4. Medication with effects on gastric motility or intestinal flora (i.e. antibiotics).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2002
- planned closingdate1-mei-2006
- Target number of participants60
- InterventionsAdding prebiotics (galacto-oligosaccharides) to premature formula.
- Primary outcome1. Number of stools/day;
2. Gutflora;
3. Safety.
- Secondary outcomeGrowth (increase in weight per kg per day).
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES E. Smit
- CONTACT for SCIENTIFIC QUERIESDr. R. Baarsma
- Sponsor/Initiator Friesland coberco dairy foods, Friesland nutrion research
- Funding
(Source(s) of Monetary or Material Support)
Friesland coberco dairy foods, Friesland Nutrion research
- PublicationsN/A
- Brief summaryPrebiotics, galacto-oligosaccharides, are present in breastfeeding and are responsable for more favourable gutflora, and fecal consistancy compared to regular premature formula fed infants. concerns have been raised, that adding prebiotics to premature formula causing looser stools may disturb fluid balance in premature infants.
We speculate that the latter will not happen since the amount of prebiotics added is less than half present in breastfeeding.
- Main changes (audit trail)
- RECORD9-sep-2005 - 18-nov-2008


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