Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula

July 31, 2017 updated by: Société des Produits Nestlé (SPN)
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • Atria Clinical Research
    • California
      • Mission Viejo, California, United States
        • Allergy and Asthma Associates of Southern California
    • Florida
      • Saint Petersburg, Florida, United States
        • All Children's Hospital
    • Georgia
      • Savannah, Georgia, United States
        • AeroAllergy
    • New York
      • New York, New York, United States
        • Mt. Sinai
      • Newburgh, New York, United States
        • ENT & Allergy Associates
    • Ohio
      • Chardon, Ohio, United States
        • Allergy and Sinus Relief Center/Great Lakes Medical research
    • Texas
      • Waco, Texas, United States
        • Allergy Asthma Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 4 years (Child)

Accepts Healthy Volunteers

No

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
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Test then Control
Subjects will perform a DBPCFC with the Test formula followed by the Control formula
Other: Test extensively hydrolyzed formula
extensively hydrolyzed formula made with a new enzyme
Other: Control extensively hydrolyzed formula
commercially available extensively hydrolyzed formula
Active Comparator: Control then Test
Subjects will perform a DBPCFC with the Control formula followed by the Test formula
Other: Test extensively hydrolyzed formula
extensively hydrolyzed formula made with a new enzyme
Other: Control extensively hydrolyzed formula
commercially available extensively hydrolyzed formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
allergic reaction
Time Frame: 2 hours post-DBPCFC
number of children who react during a DBPCFC to either formula
2 hours post-DBPCFC

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Investigators

  • Principal Investigator: Anna Nowak-Wegrzyn, MD, Mt. Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

May 7, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 21, 2015

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 31, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14.24.CLI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cow's Milk Allergy

Clinical Trials on Test extensively hydrolyzed formula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe