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Growing up milk and recurrent upper respiratory infections in children


- candidate number24441
- NTR NumberNTR5926
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jun-2016
- Secondary IDsP16-05 // NL56644.044.16 METC Enschede
- Public TitleGrowing up milk and recurrent upper respiratory infections in children
- Scientific TitleThe influence of young child formula with added short-chain galactoolichosaccharides, long-chain fructooligosaccharides and n-3 long chain polyunsaturated fatty acids on recurrent upper respiratory tract infections in children: a randomised, controlled trial
- ACRONYMGUPPIES
- hypothesisprebiotics and fatty acids will decrease the burden of recurrent respiratory infections in children
- Healt Condition(s) or Problem(s) studiedChildren, Upper respiratory tract infection
- Inclusion criteriaage 12-36 months
recurrent upper respiratory tract infections (>1 a month in the last 3 months)
familiar with cow milk drinking
understanding dutch language
written informed consent
- Exclusion criteriacow milk allergy, lactose intolerant, fish protein allergy
immunological deficiencies
atopic dermatitis
prophylactic use of antibiotics
disorders requiring a special diet
a known disorder on intestinal absorption
current use of follow up milk
chromosomal disorders
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jun-2015
- planned closingdate1-jun-2019
- Target number of participants140
- Interventionsyoung child formula with added short-chain galactoolichosaccharides, long-chain fructooligosaccharides and n-3 long chain polyunsaturated fatty acids
- Primary outcomedecrease number of days a month with upper respiratory tract infection
- Secondary outcomelaboratory parameters; immunoglobulins, hemoglobulin, vitamins
- Timepointsfollow up for 26 weeks,
- Trial web sitenone
- statusplanned
- CONTACT FOR PUBLIC QUERIESdr T.Z. Hummel
- CONTACT for SCIENTIFIC QUERIESdr T.Z. Hummel
- Sponsor/Initiator MST Enschede, ZGT Hospital, Gelre ziekenhuizen
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Nederland B.V.
- Publicationsnone
- Brief summary
- Main changes (audit trail)
- RECORD3-jun-2016 - 8-aug-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl