Prebiotics in Prevention of Atopy
PIPA
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
1 other identifier
interventional
380
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 15, 2014
CompletedFirst Posted
Study publicly available on registry
April 16, 2014
CompletedApril 16, 2014
February 1, 2011
2.3 years
April 15, 2014
April 15, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative incidence
Cumulative incidence of atopic dermatitis at 36 and 48 weeks
36 - 48 weeks
Secondary Outcomes (1)
Severity
36-48 weeks
Study Arms (3)
Breast Milk
NO INTERVENTIONBreast FED newborns
Standard Formula
PLACEBO COMPARATORStandard Formula FED newborns
Supplemented Formula
ACTIVE COMPARATORGOS/PDX Formula FED newborns
Interventions
50:50 mixture of GOS/PDX formula will be administered
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Federico II Universitylead
- Mead Johnson Nutritioncollaborator
Study Sites (1)
University of Padova - Department of Pediatrics
Padua, Italy, 35128, Italy
Related Publications (1)
Ranucci G, Buccigrossi V, Borgia E, Piacentini D, Visentin F, Cantarutti L, Baiardi P, Felisi M, Spagnuolo MI, Zanconato S, Baraldi E, Giaquinto C, Guarino A. Galacto-Oligosaccharide/Polidextrose Enriched Formula Protects against Respiratory Infections in Infants at High Risk of Atopy: A Randomized Clinical Trial. Nutrients. 2018 Mar 1;10(3):286. doi: 10.3390/nu10030286.
PMID: 29494489DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alfredo Guarino, MD
University of Naples
- PRINCIPAL INVESTIGATOR
Stefania Zanconato, MD
University of Padova
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head physician of Department of Translational Medical Science
Study Record Dates
First Submitted
April 15, 2014
First Posted
April 16, 2014
Study Start
November 1, 2011
Primary Completion
February 1, 2014
Last Updated
April 16, 2014
Record last verified: 2011-02