Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

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.

Study Overview

• Status: Completed
• Conditions: Cow Milk Allergy
• Intervention / Treatment: Other: Test extensively hydrolyzed formula; Other: Control extensively hydrolyzed formula

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Huntington Beach, California, United States, 92648
      • Hoag Medical Group
    • Mountain View, California, United States, 94040
      • Stanford University
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Clinical Research Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Midwest Clinical Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Breathe America
  • New York
    • Great Neck, New York, United States, 11021
      • Northwell Health System
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 71320
      • Allergy, Asthma and Clinical Research Center
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Carolina ENT
  • Tennessee
    • Memphis, Tennessee, United States, 38116
      • Memphis & Shelby County Pediatrics
  • Texas
    • Houston, Texas, United States, 77090
      • Houston Clinical Research Associates
    • Waco, Texas, United States, 76633
      • Allergy Asthma Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 4 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Born at term (>36 weeks gestation)
• 2 months to <4 years of age at enrollment
• Documented CMA within 6 months prior to enrollment
• Otherwise healthy
• Having obtained his/her legal representative's informed consent

Exclusion Criteria:

• Children consuming mother's milk at the time of inclusion and during the trial
• Any chromosomal or major congenital anomalies
• Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay))
• Immunodeficiency
• Anaphylaxis to any food
• Receiving free amino acid formula
• Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
• Currently participating in another clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test infant formula; Test non-commercial extensively hydrolyzed infant formula with HMOs	Other: Test extensively hydrolyzed formula; extensively hydrolyzed formula with HMOs
Active Comparator: Control infant formula; Control non-commercial extensively hydrolyzed infant formula without HMOs	Other: Control extensively hydrolyzed formula; extensively hydrolyzed formula without HMOs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
allergic reaction post DBPCFC	subjects will be observed during and for at least 2 hours after the food challenge for any allergic reaction symptoms which will be documented by investigators	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stool characteristics	collected on daily diaries	1 week
formula intake	amount of formula ingested daily	1 week
adverse events	adverse events as reported by caregivers	1 week

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Anna Nowak-Wegrzyn, MD, Mt Sinai

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2017
• Primary Completion (Actual): November 6, 2018
• Study Completion (Actual): November 6, 2018

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: 16.16.CLI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No