No registrations found.
ID
Source
Brief title
Sponsors and support
Dr. J.L. Kiers
P.O. Box 159
6710 BD Ede, The Netherlands
0031-318-439434
Intervention
Outcome measures
Primary outcome
Growth parameters.
Secondary outcome
Gutflora (tested with quantative PCR)
hours of crying, sleeping etc
defecation patterns.
Background summary
This 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.
Study objective
Probiotics are tolerated well by infants (age 0-3 months) and results in a microbial flora resembling that of breastfed infants.
Intervention
All infants receive formula feeding for the first three months, 75 with probiotics (L. casei and B. animalis) and 75 without.
P.O. Box 2500
Arine M. Vlieger
Koekoekslaan 1
Nieuwegein 3430 EM
The Netherlands
+31 (0)30 6092071
P.O. Box 2500
Arine M. Vlieger
Koekoekslaan 1
Nieuwegein 3430 EM
The Netherlands
+31 (0)30 6092071
Inclusion criteria
1. Healthy, term neonate;
2. Age < 7 days;
3. Informed consent;
4. Parents are fluent in Dutch.
Exclusion criteria
1. Antibiotics postpartum;
2. Congenital malformations etc.
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 | NL275 |
| NTR-old | NTR313 |
| Other | : N/A |
| ISRCTN | ISRCTN78225533 |