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Prebiotics in Prevention of Atopy (PIPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02116452
Recruitment Status : Completed
First Posted : April 16, 2014
Last Update Posted : April 16, 2014
Mead Johnson Nutrition
Information provided by (Responsible Party):
Alfredo Guarino, 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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Dietary Supplement: Supplemented Formula Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : November 2011
Actual Primary Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
No Intervention: Breast Milk
Breast FED newborns
Placebo Comparator: Standard Formula
Standard Formula FED newborns
Active Comparator: Supplemented Formula
GOS/PDX Formula FED newborns
Dietary Supplement: Supplemented Formula
50:50 mixture of GOS/PDX formula will be administered

Primary Outcome Measures :
  1. Cumulative incidence [ Time Frame: 36 - 48 weeks ]
    Cumulative incidence of atopic dermatitis at 36 and 48 weeks

Secondary Outcome Measures :
  1. Severity [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02116452

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University of Padova - Department of Pediatrics
Padova, Italy, 35128
Sponsors and Collaborators
Federico II University
Mead Johnson Nutrition
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Principal Investigator: Alfredo Guarino, MD University of Naples
Principal Investigator: Stefania Zanconato, MD University of Padova

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alfredo Guarino, Head physician of Department of Translational Medical Science, Federico II University Identifier: NCT02116452     History of Changes
Other Study ID Numbers: PIPA
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: February 2011

Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases