Milk Hypersensitivity
Conditions
Keywords
allergy, cow's milk, sensibilisation, fermented milk, infant formula
Brief summary
Impact of fermented milk in prevention of cow's milk allergy in new born and infants
Interventions
OTHERFermented milk
Formula used for non breastfed children or in complement of breastfeeding
OTHERStandard milk
Formula used for non breastfed children or in complement of breastfeeding
Sponsors
Optimed Medizinische Instrumente GmbH
Bledina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* mother before the 5th month of pregnancy * mother agreeing to stop consumption of yogurts and fermented milks during the 3rd quarter of pregnancy * mother agreeing to receive a calcium supplementation during the 3rd quarter of pregnancy * atopic mother or father and at least another atopic member (sister or brother) * parents having given written informed consent * adhesion to eviction regimen for mother and child * parents agreeing with a regular follow-up (3 visits and monthly phone call with the dietician)
Exclusion criteria
* mother in an exclusion period from another study * parents refusing to sign the informed consent * infant in a situation which could interfere with an optimal participation to the study, or which could represent a risk for the infant, according to the investigator * known or suspected immunodeficiency in the family
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensibilisation and cow's milk allergy | 4, 12 and 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Sensitization or allergy to other allergens | 4, 12 and 24 months |
| Atopic diseases (atopic dermatitis, asthma) | 4, 12 and 24 months |
Countries
France
Outcome results
None listed