Prebiotics in Prevention of Atopy

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Dietary Supplement: Supplemented Formula

• Registration Number: NCT02116452
• Lead Sponsor: Federico II University

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.

Study Timeline

• Status Verified: 2011-02
• Study Start: 2011-11
• Primary Completion: 2014-02
• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-15
• Last Update Submitted: 2014-04-15
• Study First Posted: 2014-04-16
• Last Update Posted: 2014-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supplemented Formula	Supplemented Formula	GOS/PDX Formula FED newborns

Primary Outcome Measures

Name	Time	Method
Cumulative incidence	36 - 48 weeks	Cumulative incidence of atopic dermatitis at 36 and 48 weeks

Secondary Outcome Measures

Name	Time	Method
Severity	36-48 weeks	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

Trial Locations

Locations (1)

University of Padova - Department of Pediatrics; 🇮🇹 Padova, Italy