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Study on the effects of a growing-up milk (GUM)on infections in healthy children

Intervention study on the effects of a growing-up milk (GUM) containing intact proteins, milk fat and a prebiotic on incidence and duration of respiratory and gastrointestinal infections in healthy children between 1 and 3 years of age.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON19929
Enrollment
464
Registered
2014-09-11
Start date
2015-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Upper respiratory tract infections (URTI) Gastrointestinal tract infections (GITI)

Interventions

GUM A: containing intact active proteins, milk fat, and a prebiotic GUM B: containing only intact active proteins GUM C: containing a prebiotic GUM REF: commercial available growing up milk

Sponsors

Chinese University of Hong Kong
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Apperently healthy - Between 1 and 2.5 years of age at inclusion, with a preference of 1-1.5 years - Boys and Girls of Chinese origin, living in Hong Kong - Able and willing to drink 400 ml milk per day (2 servings of 200 ml each) - Singned informed consent

Exclusion criteria

Exclusion criteria: - Underweight, wasting, or stunting (according to WHO criteria) - Clinically significant congenital diseases - In sick condition within two weeks prior to screening visit - Receive antibiotics, anti-viral drugs, montelukast, laxatives, or anti-diarrhoeal drug within 1 month before intervention starts - Any breastfeeding within last 2 months before intervention starts - Suspected tuberculosis by clinical or radiological examination or from history of contact with index patient with confirmed tuberculosis - Cow's milk allergy - History of severe allergic diseases (mild eczema of mild asthma is NOT excluded if unrelated to cow's milk allergy) - Usage of systemic immunosuppressive drugs within 3 months prior to screening visit (incidental use of topical, inhalational and intranasal corticosteroids are allowed) - Received rotavaccin ever - Received influenze vaccin within 12 months prior to recruitment - History of lactose intolerance - Siblings of already recruited children that are living in the same household with the exception of twins that can be allocated to the same group - Participation in another clinical trial at the same time or within 2 months prior to intervention starts - Children from mothers or caregivers whoare illiterate or unable to read and write Chinese - Premature (<37 weeks of gestation) at birth - No full committment of parents to omit dairy drinks from the child's diet during the study and replace these by the supplied growing up milk 4-apr-2016: One criterion on siblings changed into “Siblings of already recruited children that are living in the same household with the exception of twins that can be allocated to the same group. Recruitment of younger sibling of a subject (older sibling) from the same household is allowed provided that the subject (older sibling) has ended his/her participation in this study and the family returned unused GUM to the study site. The allocation of treatment group for the younger sibling will be independent of that for the older sibling.”

Design outcomes

Primary

MeasureTime frame
- Incidence of URTI (Upper respiratory tract infections) - Duration of GITI (Gastrointestinal tract infections)

Secondary

MeasureTime frame
- Duration of URTI - Incidence of GITI - Nutritional status

Contacts

Public ContactI. Bovee

Senior Nutritional Study Expert at FrieslandCampina

ingeborg.bovee@frieslandcampina.com-

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)