J45 J06 T78.4
Conditions
Interventions
Group 1: Test milk
mildly pasteurized, not further processed cow's milk
from 6 to 9 months: daily 200ml milk
from 10 to 35 months: twice daily 150ml milk
Group 2: Regularly processed cow's milk
from 10 to 35 months: twice daily 150ml milk
Sponsors
Klinikum der Universität München - Dr. von Haunersches Kinderspital
Eligibility
Sex/Gender
All
Age
6 Months to 12 Months
Inclusion criteria
Inclusion criteria: Healthy, term-born (35 gestational weeks) infants of both sexes; Age 6 to 12 months at randomization; Caregivers with the ability to follow study instructions and likely to attend and complete all required visits; Caregivers have a mobile phone or a personal computer and are likely to keep a web-based diary regularly; Written informed consent of the parents or guardians
Exclusion criteria
Exclusion criteria: Suspected or confirmed cow’s milk allergy, milk intolerance, lactose intolerance, suspected immunodeficiency, cystic fibrosis, failure to thrive; Simultaneous participation in another intervention study; Maternal age below 18 years; Uncertainty of the study physician about prospective adherence to study protocol, e.g. known or persistent abuse of medication, drugs or alcohol in caregivers; A sibling already enrolled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atopic sensitization at age 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Physician diagnosis of asthma until age 5; Rhinitis irrespective of cough and wheeze until age 3 years; Respiratory tract infections without wheeze until age 3 years; Otitis media until age 3 years; Atopic eczema at age 3 years; Levels of high-sensitivity C-reactive protein in serum at age 3 years | — |
Countries
Germany
Outcome results
None listed