NCT02116452

Prebiotics in Prevention of Atopy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 1 Week – 24 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Supplemented Formula	50:50 mixture of GOS/PDX formula will be administered

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-02-01
• First posted: 2014-04-16
• Last updated: 2014-04-16

Locations

1 site across 1 country: Italy