No registrations found.
ID
Source
Brief title
Health condition
Gestational age less then 34 weeks
birtheight below 1700 grams.
Sponsors and support
friesland nutrion research
Pieter Stuyvesantweg 1
8937 AC Leeuwarden
the Netherlands
Intervention
Outcome measures
Primary outcome
1. Number of stools/day;
2. Gutflora;
3. Safety.
Secondary outcome
Growth (increase in weight per kg per day).
Background summary
Prebiotics, 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.
Study objective
Prebiotics 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.
Study design
N/A
Intervention
Adding prebiotics (galacto-oligosaccharides) to premature formula.
P.O. Box 50000
E. Smit
Enschede 7500 KA
The Netherlands
+31 (0)53 4872000
P.O. Box 50000
E. Smit
Enschede 7500 KA
The Netherlands
+31 (0)53 4872000
Inclusion criteria
1. Gestational age less then 34 weeks;
2. Birthweight less then 1700 grams.
Exclusion criteria
1. Congenital defects;
2. Motility disorders of the gut;
3. Necrotising enterocolitis;
4. Medication with effects on gastric motility or intestinal flora (i.e. antibiotics).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL277 |
| NTR-old | NTR315 |
| Other | : N/A |
| ISRCTN | ISRCTN87058658 |