To evaluate whether YCF with added scGOS/lcFOS and n-3 LCPFUAs can decrease the number of upper respiratory tract infections compared to cow*s milk in children aged 12-36 months with recurrent upper respiratory tract infections.
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is:
• The total number of episodes of upper respiratory tract infections during the
six month study period.
Secondary outcome
Secondary study parameters are:
- The average number of days a month with symptoms of an upper respiratory
tract infection in the last three months of the study.
- Influence of growing up milk, compared to cow*s milk, on:
• iron status markers; Hb, mean cell volume (MCV), reticulocyte count,
ferritin, soluble transferrin receptor (change from baseline);
• vitamin A, D and C status (change from baseline);
• number of days absence of parents from work and (recorded by parents);
• the number courses of prescribed antibiotics (recorded by parents).
Explorative study parameters are
- Influence of growing up milk, compared to cow*s milk, on:
• levels of immunoglobulins A, G and M in serum and IgA in saliva (change from
baseline);
• serum zinc levels (change from baseline)
Background summary
Recurrent upper respiratory tract infections are a common problem with a great
number of days with illness for young children. At the moment there is no
suitable treatment for patients with an idiopathic cause of recurrent upper
respiratory tract infections. This can lead to an increased burden in parental
concern and productivity, as well as unnecessary prescription of antibiotics. A
recent studie suggests a beneficial effect of young child formula (YCF) with
added short chain galactooligosacharides, long-chain fructooligosaccharides
(scGOS/lcFOS) and n-3 long-chain polyunsaturated fatty acids (n-3 LCPFUAs) on
infections in children attending day care. There are no randomised controlled
trials yet that have investigated the effects of this product in children with
recurrent URTI.
Study objective
To evaluate whether YCF with added scGOS/lcFOS and n-3 LCPFUAs can decrease the
number of upper respiratory tract infections compared to cow*s milk in children
aged 12-36 months with recurrent upper respiratory tract infections.
Study design
A multicentre, open, randomised controlled trial will be performed
Intervention
Intervention group: 300 ml YCF with added scGOS/lcFOS and n-3 LCPFUAs per day
Control group: 300 ml cow's milk per day
Study burden and risks
The dietary advice is not complex and risk-free. The only burden includes one
extra venapunction and time to fill in the diaries. The time investment for the
follow-up consults equals to standard care.
Koningsplein 1
Enschede 7512 KZ
NL
Koningsplein 1
Enschede 7512 KZ
NL
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56644.044.16 |
| Other | volgt |