The influence of young child formula containing short-chain galactooligosaccharides, long-chain fructooligosaccharides and n-3 long-chain polyunsaturated fatty acids on recurrent upper respiratory tract infections in children: a randomised, controlled trial.
- Conditions
- ailing toddlersRecurrent upper respiratory tract infections1004743810024970
- Registration Number
- NL-OMON47616
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Children between 12-36 months of age.
Recurrent upper respiratory tract infections (>=3 in the last three months).
Familiar with and currently drinking milk products; expected study product
intake of 300 ml per day.
Understanding of Dutch language by parents.
Written informed consent.
Immunological deficiencies.
Atopic dermatitis according to the Hannifin criteria.
Known or suspected disorder of intestinal absorption.
Prophylactic use of antibiotics.
Children with allergies or intolerances for lactose, milk protein or fish
protein
Disorders requiring a special diet.
Expected or foreseen inability of the subject and/or their families to adhere
to protocol
instructions, including daily completion of the diary by the parents
Any relevant congenital abnormality, anatomical abnormality, chromosomal
disorder or severe disease.
Current use of growing up milk.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is:<br /><br>• The total number of episodes of upper respiratory tract infections during the<br /><br>six month study period.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters are:<br /><br>- The average number of days a month with symptoms of an upper respiratory<br /><br>tract infection in the last three months of the study.<br /><br>- Influence of growing up milk, compared to cow*s milk, on:<br /><br>• iron status markers; Hb, mean cell volume (MCV), reticulocyte count,<br /><br>ferritin, soluble transferrin receptor (change from baseline);<br /><br>• vitamin A, D and C status (change from baseline);<br /><br>• number of days absence of parents from work and (recorded by parents);<br /><br>• the number courses of prescribed antibiotics (recorded by parents).<br /><br><br /><br>Explorative study parameters are<br /><br>- Influence of growing up milk, compared to cow*s milk, on:<br /><br>• levels of immunoglobulins A, G and M in serum and IgA in saliva (change from<br /><br>baseline);<br /><br>• serum zinc levels (change from baseline)</p><br>