No registrations found.
ID
Source
Brief title
Health condition
Heathy term infants with intercurrent diseases: diarrhoea and respiratory infections.
Sponsors and support
Global Development Centre
P.Stuyvesantweg 1
Leeuwarden
8937 AC
Netherlands
rob.tebiesebeke@frieslandfoods.com
Performer: Dr Diny van Zoeren-Grobben
Isala Clinics
Neonatal Unit
Dr van Heesweg 2
Zwolle
8025 AB
Netherlands
Tel: *31-38-4247073
Fax: *31-38-4247667
Email: d.van.zoeren@isala.nl
Intervention
Outcome measures
Primary outcome
- Frequency, incidence and duration of diarrhoea and respiratory infections
composition of gut flora
Secondary outcome
- Growth (head circumference, lenght and weight)
- Feeding tolerance (pattern of defecation, consistence of faeces, crying, vomiting, stomach ache)
Background summary
We speculate that the combination of pre and probiotics is better protective than only one of these substances. Supplementation of the combination of pre- and probiotics may reduce the incidence of infections to the same level as human milk fed infants.
Supplementation of infant formula with a combination of pre- and probiotics may protect infants against infectious complications such as diarrhoea and respiratory infections.
Study objective
Supplementation of infant formula with a combination of pre- and probiotics may protect infants against infectious complications such as diarrhoea and respiratory infections. We speculate that the combination of pre and probiotics is better protective than only one of these substances. Supplementation of the combination of pre- and probiotics may reduce the incidence of infections to the same level as human milk fed infants.
Study design
1 - Frequency, incidence and duration of diarrhoea and respiratory infections, feeding tolerance : 2 weekly
2 - Antropometry: t=0, T = 3 and T=6 mths
3 - Fecal samples: T=0, T=3 and T=6 months
Intervention
Supplementation of infant formula with an combination of pre- and probiotics.
Pieter Stuyvesantweg 1
R. Biesebeke, te
Leeuwarden 8937 AC
The Netherlands
++31612504012
rob.tebiesebeke@frieslandfoods.com
Pieter Stuyvesantweg 1
R. Biesebeke, te
Leeuwarden 8937 AC
The Netherlands
++31612504012
rob.tebiesebeke@frieslandfoods.com
Inclusion criteria
1. Healthy term infants with a postmenstrual age of 37-42 weeks
2. Birth weight between P10 and P90
3. Informed consent of both parents
Exclusion criteria
1. Neonatal sepsis
2. Severe congenital malformations
3. Birth asphyxia (apgar < 6 at 5 minutes, and/or umbilical cord pH < 7.00 and/or necessity of reanimation)
4. Admission to a pediatric ward
5. No Dutch or English speaking parents
6. Antibiotics to the mother during labour
7. Antibiotics to the infant in the first week of life
8. History of allergy with parents or sibs
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 | NL1442 |
| NTR-old | NTR1503 |
| Other | : 06-1178 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
Summary results
2) Effect of supplementation of of infant formula with a a combination of pre- and probiotics on the composition of gut flora.