Prebiotics in Prevention of Atopy

Atopic Dermatitis Clinical Trial

— PIPA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116452
• Other study ID #: PIPA
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2014
• Last updated: April 15, 2014
• Start date: November 2011

Study information

• Verified date: February 2011
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Dietary Supplement:
• Supplemented Formula
50:50 mixture of GOS/PDX formula will be administered

Locations

Country	Name	City	State
Italy	University of Padova - Department of Pediatrics	Padova

Sponsors (2)

Lead Sponsor	Collaborator
Federico II University	Mead Johnson Nutrition

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence	Cumulative incidence of atopic dermatitis at 36 and 48 weeks	36 - 48 weeks	Yes
Secondary	Severity	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	36-48 weeks	Yes