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The role of pre- and probiotics in infections in term infants.

The role of pre- and probiotics in infections in term infants.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26255
Enrollment
225
Registered
2008-10-23
Start date
2007-01-04
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heathy term infants with intercurrent diseases: diarrhoea and respiratory infections.

Interventions

Supplementation of infant formula with an combination of pre- and probiotics.

Sponsors

Sponsor: Dr R te Biesebeke 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
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
- Frequency, incidence and duration of diarrhoea and respiratory infections composition of gut flora

Secondary

MeasureTime frame
- Growth (head circumference, lenght and weight) - Feeding tolerance (pattern of defecation, consistence of faeces, crying, vomiting, stomach ache)

Contacts

Public ContactR. Biesebeke, te

Friesland Foods Pieter Stuyvesantweg 1

rob.tebiesebeke@frieslandfoods.com++31612504012

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)