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


- candidate number4265
- NTR NumberNTR1503
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-okt-2008
- Secondary IDs06-1178 
- Public TitleThe role of pre- and probiotics in infections in term infants.
- Scientific TitleThe role of pre- and probiotics in infections in term infants.
- ACRONYMHIPPO
- hypothesisSupplementation 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.
- Healt Condition(s) or Problem(s) studiedRespiratory tract infection, Prebiotics, Probiotics, Diarrhea, Infants
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 4-jan-2007
- planned closingdate4-jan-2009
- Target number of participants225
- InterventionsSupplementation of infant formula with an combination of pre- and probiotics.
- 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)
- Timepoints1 - 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
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. R. Biesebeke, te
- CONTACT for SCIENTIFIC QUERIESDr. Diny Zoeren-Grobben, van
- Sponsor/Initiator Friesland Foods, Leeuwarden (Global Development Centre), Isala Clinics; Neonatal Unit
- Funding
(Source(s) of Monetary or Material Support)
Isala Clinics; Neonatal Unit , Friesland Foods, Leeuwarden (Global Development Centre),
- Publications1) Effect of supplementation of infant formula with a a combination of pre- and probiotics on incidence and duration of infectious complications in term infants.

2) Effect of supplementation of of infant formula with a a combination of pre- and probiotics on the composition of gut flora.
- Brief summaryWe 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.
- Main changes (audit trail)
- RECORD23-okt-2008 - 29-okt-2008


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