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.

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. - Growing up milk and recurrent upper respiratory infections in children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47616

Enrollment

150

Registered

2016-05-12

Start date

2016-11-11

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

ailing toddlers Recurrent upper respiratory tract infections

Interventions

Intervention group: 300 ml YCF with added scGOS/lcFOS and n-3 LCPFUAs per day Control group: 300 ml cow's milk per day

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The main study parameter is: • The total number of episodes of upper respiratory tract infections during the six month study period.	—

Secondary

Measure	Time frame
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 cows 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 cows milk, on: • levels of immunoglobulins A, G and M in serum and IgA in saliva (change from baseline); • serum zinc levels (change from baseline)	—

Measure

Time frame

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)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)