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Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

NCT03236207 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2019-01-30

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 Milk Allergy

Interventions

OTHER

Test extensively hydrolyzed formula

extensively hydrolyzed formula with HMOs

OTHER

Control extensively hydrolyzed formula

extensively hydrolyzed formula without HMOs

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

  • Anna Nowak-Wegrzyn, MD · Mt Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
2 Months
Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-06
Primary Completion
2018-11-06
Completion
2018-11-06

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 NCT03236207 on ClinicalTrials.gov