PIPA

The intestinal microbiota seems to play an important role in inducing tolerance to orally introduced antigens and therefore to be involved in the pathogenesis of allergic pathologies. Nutrition in the first months of life plays an important role in modulating the intestinal bacterial composition: mother's milk is rich in indigestible oligosaccharides which promote the growth of intestinal bacteria, especially bifidobacteria.

Objectives:
To test the hypothesis that the GOS/PDX prebiotic may have a preventive effect against atopic dermatitis, respiratory and gastrointestinal tract infections in infants at risk of atopy. In children with early-onset Atopic Dermatitis, test the efficacy of the prebiotic in reducing the severity of the disease.

Methods
Prospective randomized double-blind study comparing formula supplemented with GOS/PDX (Enfamil Premium Infant 1) and standard formula (Enfamil Premium 1).

Population
240 newborns at risk of allergy will be enrolled, ie having at least one parent or sibling with a current or previous medical diagnosis of atopic disease (asthma, allergic rhinoconjunctivitis, atopic dermatitis, allergic urticaria, food allergy). Upon enrollment (within the first 4 weeks of life) subjects will be randomized 1:1 to receive:
a) formula supplemented with GOS/PDX
or
b) standard formula
and they will continue the study only if the formula is introduced by the end of the sixth month of life. In this case they will take the formula up to 12 months.

Primary objectives
• Incidence of atopic dermatitis at 9 months.
• Assessment of the severity of atopic dermatitis using the Scorad score at 9 months
• Number of episodes of Atopic Dermatitis and difference in SCORAD score at 9 months compared to the mean of all patients

Secondary objectives
• Incidence of respiratory infections at 9 months
• Cumulative incidence of atopic dermatitis at 24 months
• Total duration (in days) of atopic dermatitis and therapies implemented at 9 months of age
• Incidence of episodes of acute diarrhea at 9 and 24 months
• Assessment of nutritional status (weight gain, weight Z-score, height)
• Cumulative incidence of other allergic manifestations: asthma, allergic urticaria, rhinoconjunctivitis, food allergy, cow's milk protein allergy (at 9 and 24 months of age)

In a subgroup of 100 children intestinal inflammation will be evaluated by measuring non-invasive markers: faecal calprotectin levels (ELISA test), Eosinophil Cation Protein (ELISA) and faecal IgA.
In the same group of children, intestinal microflora will be evaluated using molecular biology techniques.