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Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula

NCT02711163 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-05-15

No results posted yet for this study

Summary

The aim of this study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a double blind placebo controlled food challenge, followed by a 3-month open feeding period.

Conditions

  • Cow Milk Allergy

Interventions

DIETARY_SUPPLEMENT

Extensively Hydrolyzed formula

DIETARY_SUPPLEMENT

Amino acid formula

Sponsors & Collaborators

  • United Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Salvatore Cucchiara · University Hospital Umberto I

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
1 Month
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-08-31
Completion
2017-11-29

Countries

  • Italy

Study Locations

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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 NCT02711163 on ClinicalTrials.gov