Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula

Not Applicable

Completed

• Conditions: Cow's Milk Allergy
• Interventions: Other: Test extensively hydrolyzed formula; Other: Control extensively hydrolyzed formula

• Registration Number: NCT02450643
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-21
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control then Test	Test extensively hydrolyzed formula	Subjects will perform a DBPCFC with the Control formula followed by the Test formula
Test then Control	Control extensively hydrolyzed formula	Subjects will perform a DBPCFC with the Test formula followed by the Control formula
Test then Control	Test extensively hydrolyzed formula	Subjects will perform a DBPCFC with the Test formula followed by the Control formula
Control then Test	Control extensively hydrolyzed formula	Subjects will perform a DBPCFC with the Control formula followed by the Test formula

Primary Outcome Measures

Name	Time	Method
allergic reaction	2 hours post-DBPCFC	number of children who react during a DBPCFC to either formula

Secondary Outcome Measures

Name	Time	Method
formula intake	1 week	amount of formula ingested as collected on daily diaries
adverse events	1 week	any adverse event reported by caregivers
stool characteristics	1 week	stool descriptors as collected on daily diaries

Trial Locations

Locations (8)

AeroAllergy; 🇺🇸 Savannah, Georgia, United States

Allergy Asthma Research Institute; 🇺🇸 Waco, Texas, United States

Atria Clinical Research; 🇺🇸 Little Rock, Arkansas, United States

Allergy and Asthma Associates of Southern California; 🇺🇸 Mission Viejo, California, United States

Mt. Sinai; 🇺🇸 New York, New York, United States

ENT & Allergy Associates; 🇺🇸 Newburgh, New York, United States

Allergy and Sinus Relief Center/Great Lakes Medical research; 🇺🇸 Chardon, Ohio, United States

All Children's Hospital; 🇺🇸 Saint Petersburg, Florida, United States