Prebiotics in Prevention of Atopy

NCT02116452 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2014-04-16

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Supplemented Formula

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

Sponsors & Collaborators

  • Mead Johnson Nutrition

    collaborator INDUSTRY
  • Federico II University

    lead OTHER

Principal Investigators

  • Alfredo Guarino, MD · University of Naples

  • Stefania Zanconato, MD · University of Padova

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
24 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-02-28

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02116452 on ClinicalTrials.gov