Atopic Dermatitis
Conditions
Brief summary
The study objective is to evaluate whether a specific prebiotic (GOS/PDX) may have an effect in preventing atopic dermatitis, food allergy, intestinal and/or respiratory infections in infants at risk of atopy. In infants with dermatitis, the hypothesis will be tested that prebiotics reduce the severity of the disease.
Detailed description
This study is a prospective, double blind, randomised, 24 month study trial comparing formula with 50/50 mixture of GOS/PDX (Enfamil Premium Infant Formula 1 for children \<6 months and Formula 2 for children ≥ 6 months) versus standard formula (Enfamil Premium Formula 1 and 2). Study population is composed by newborns at risk for allergy that will be identified at time of delivery. Infants will be eligible if at least one parent or one older sibling have a physician-diagnosed atopic disease (asthma, allergic rhinoconjunctivitis , atopic dermatitis, allergic urticaria, and food allergy as follow described. At time of enrolment (within the first 4 weeks of life) infants will be randomised 1:1 to receive once they will start formula feeding before the day of the 6th month birthday.
Interventions
DIETARY_SUPPLEMENTSupplemented Formula
50:50 mixture of GOS/PDX formula will be administered
Sponsors
Mead Johnson Nutrition
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 24 Weeks
Healthy volunteers
No
Inclusion criteria
1. Gestational age \>37 and \< 42 weeks. 2. Birth weight \> 2500 gr. 3. At risk of atopy (see appendix 1). 4. Informed consent signed by the parents (see appendix 3).
Exclusion criteria
1. Congenital immunodeficiency 2. Severe congenital disorders or malformations 3. Born to mother with diabet 4. Long term intake (\> 7 consecutive days) of pro- or prebiotics 5. Children who have already assumed ≥ 50 mL for feeding bottle of Formulas different from the one object of this study for up to a month. 6. Parents expected not to be compliant with the study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence | 36 - 48 weeks | Cumulative incidence of atopic dermatitis at 36 and 48 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity | 36-48 weeks | Severity of atopic dermatitis as judged by the SCORAD score at 36 and 48 weeks and its distribution in three different groups: mild (\<15 SCORAD points), moderate (15-40 SCORAD points), and severe (\>40 SCORAD points) according to the objective components of the index |
Countries
Italy
Outcome results
None listed