Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
380 participants
INTERVENTIONAL
2011-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Breast Milk
Breast FED newborns
No interventions assigned to this group
Standard Formula
Standard Formula FED newborns
No interventions assigned to this group
Supplemented Formula
GOS/PDX Formula FED newborns
Supplemented Formula
50:50 mixture of GOS/PDX formula will be administered
Interventions
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Supplemented Formula
50:50 mixture of GOS/PDX formula will be administered
Eligibility Criteria
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Inclusion Criteria
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
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
1 Week
24 Weeks
ALL
No
Sponsors
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Mead Johnson Nutrition
INDUSTRY
Federico II University
OTHER
Responsible Party
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Alfredo Guarino
Head physician of Department of Translational Medical Science
Principal Investigators
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Alfredo Guarino, MD
Role: PRINCIPAL_INVESTIGATOR
University of Naples
Stefania Zanconato, MD
Role: PRINCIPAL_INVESTIGATOR
University of Padova
Locations
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University of Padova - Department of Pediatrics
Padua, Italy, Italy
Countries
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References
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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.
Other Identifiers
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PIPA
Identifier Type: -
Identifier Source: org_study_id
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