The role of pre- and probiotics in infections in term infants.
Recruiting
- Conditions
- Heathy term infants with intercurrent diseases: diarrhoea and respiratory infections.
- Registration Number
- NL-OMON26255
- Lead Sponsor
- Sponsor: Dr R te Biesebeke Global Development CentreP.Stuyvesantweg 1 Leeuwarden8937 ACNetherlands rob.tebiesebeke@frieslandfoods.comPerformer: Dr Diny van Zoeren-Grobben Isala Clinics Neonatal Unit Dr van Heesweg 2 Zwolle8025 ABNetherlands Tel: *31-38-4247073 Fax: *31-38-4247667 Email: d.van.zoeren@isala.nl
- Brief Summary
1) Effect of supplementation of infant formula with a a combination of pre- and probiotics on incidence and duration of infectious complications in term infants. <br><br> 2) Effect of supplementation of of infant formula with a a combination of pre- and probiotics on the composition of gut flora.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 225
Inclusion Criteria
1. Healthy term infants with a postmenstrual age of 37-42 weeks
2. Birth weight between P10 and P90
Exclusion Criteria
1. Neonatal sepsis
2. Severe congenital malformations
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Frequency, incidence and duration of diarrhoea and respiratory infections <br>composition of gut flora
- Secondary Outcome Measures
Name Time Method - Growth (head circumference, lenght and weight) <br /><br>- Feeding tolerance (pattern of defecation, consistence of faeces, crying, vomiting, stomach ache)<br />