Prebiotics in Prevention of Atopy (PIPA)

Federico II University

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Dietary Supplement: Supplemented Formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02116452

PIPA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 patients

Sex: All

Ages: 1 to 24 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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380 participants in 3 patient groups, including a placebo group

Breast Milk

No Intervention group

Description:

Breast FED newborns

Standard Formula

Placebo Comparator group

Description:

Standard Formula FED newborns

Supplemented Formula

Active Comparator group

Description:

GOS/PDX Formula FED newborns

Treatment:

Dietary Supplement: Supplemented Formula