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Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula

NCT02450643 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2017-08-01

No results posted yet for this study

Summary

Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.

Conditions

  • Cow's Milk Allergy

Interventions

OTHER

Test extensively hydrolyzed formula

extensively hydrolyzed formula made with a new enzyme

OTHER

Control extensively hydrolyzed formula

commercially available extensively hydrolyzed formula

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

  • Anna Nowak-Wegrzyn, MD · Mt. Sinai

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
2 Months
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States

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 NCT02450643 on ClinicalTrials.gov