Prebiotics in Prevention of Atopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of GOS/PDX Supplemented Formula in Preventing and Modifying the History of Allergy and Acute Infections in a Population of Infants at Risk of Atopy

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Dietary Supplement: Supplemented Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age >37 and < 42 weeks. Birth weight > 2500 gr. At risk of atopy (see appendix 1). Informed consent signed by the parents (see appendix 3). Exclusion Criteria: Congenital immunodeficiency Severe congenital disorders or malformations Born to mother with diabet Long term intake (> 7 consecutive days) of pro- or prebiotics 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. Parents expected not to be compliant with the study procedures

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 24 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Breast Milk<br>Breast FED newborns | |
| Placebo Comparator: Standard Formula<br>Standard Formula FED newborns | |
| Active Comparator: Supplemented Formula<br>GOS/PDX Formula FED newborns | Dietary Supplement: Supplemented Formula<br>* 50:50 mixture of GOS/PDX formula will be administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence | Cumulative incidence of atopic dermatitis at 36 and 48 weeks | 36 - 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity | 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 | 36-48 weeks |