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| Name | Class |
|---|---|
| Mead Johnson Nutrition | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Milk | No Intervention | Breast FED newborns | |
| Standard Formula | Placebo Comparator | Standard Formula FED newborns | |
| Supplemented Formula | Active Comparator | GOS/PDX Formula FED newborns |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplemented Formula | Dietary Supplement | 50:50 mixture of GOS/PDX formula will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence | Cumulative incidence of atopic dermatitis at 36 and 48 weeks | 36 - 48 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfredo Guarino, MD | University of Naples | Principal Investigator |
| Stefania Zanconato, MD | University of Padova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Padova - Department of Pediatrics | Padova | Italy | 35128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29494489 | Derived | Ranucci G, Buccigrossi V, Borgia E, Piacentini D, Visentin F, Cantarutti L, Baiardi P, Felisi M, Spagnuolo MI, Zanconato S, Baraldi E, Giaquinto C, Guarino A. Galacto-Oligosaccharide/Polidextrose Enriched Formula Protects against Respiratory Infections in Infants at High Risk of Atopy: A Randomized Clinical Trial. Nutrients. 2018 Mar 1;10(3):286. doi: 10.3390/nu10030286. |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |