Clinical trial NCT02116452: Prebiotics in Prevention of Atopy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Federico II University
Sponsor class: OTHER
Collaborators: name: Mead Johnson Nutrition
First posted: 2014-04-16
Enrollment: 380
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence
timeFrame: 36 - 48 weeks
Secondary outcomes:
measure: Severity
timeFrame: 36-48 weeks
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University of Padova - Department of Pediatrics
Study officials:
affiliation: University of Naples
name: Alfredo Guarino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Padova
name: Stefania Zanconato, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.