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Completed

NCT Number: NCT02116452

Prebiotics in Prevention of Atopy

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

1 week–24 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Padova - Department of Pediatrics

Padova, Italy, 35128

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age >37 and < 42 weeks.
  • Birth weight > 2500 gr.
  • At risk of atopy (see appendix 1).
  • Informed consent signed by the parents (see appendix 3).

Exclusion criteria

  • Congenital immunodeficiency
  • Severe congenital disorders or malformations
  • Born to mother with diabet
  • Long term intake (> 7 consecutive days) of pro- or prebiotics
  • 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.
  • Parents expected not to be compliant with the study procedures

Treatment and study plan

Supplemented Formula

Dietary Supplement

50:50 mixture of GOS/PDX formula will be administered

Primary outcomes

  1. Cumulative incidence

    Time frame: 36 - 48 weeks

    Cumulative incidence of atopic dermatitis at 36 and 48 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Collaborators

  • Mead Johnson Nutrition

Registry information

Official study 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

Acronym: PIPA

Important dates

Study start
2011
Primary completion
2014
First posted
Apr 16, 2014
Registry last updated
Apr 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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