Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

Not Applicable

Completed

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

• Registration Number: NCT03236207
• 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: 2017-07-06
• Study First Submitted: 2017-07-19
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-08-01
• Primary Completion: 2018-11-06
• Study Completion: 2018-11-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test infant formula	Test extensively hydrolyzed formula	Test non-commercial extensively hydrolyzed infant formula with HMOs
Control infant formula	Control extensively hydrolyzed formula	Control non-commercial extensively hydrolyzed infant formula without HMOs

Primary Outcome Measures

Name	Time	Method
allergic reaction post DBPCFC	2 hours	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

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Hoag Medical Group; 🇺🇸 Huntington Beach, California, United States

Carolina ENT; 🇺🇸 Orangeburg, South Carolina, United States

Houston Clinical Research Associates; 🇺🇸 Houston, Texas, United States

Breathe America; 🇺🇸 Albuquerque, New Mexico, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Stanford University; 🇺🇸 Mountain View, California, United States

Clinical Research Institute; 🇺🇸 Plymouth, Minnesota, United States

Midwest Clinical Research; 🇺🇸 Saint Louis, Missouri, United States

Memphis & Shelby County Pediatrics; 🇺🇸 Memphis, Tennessee, United States

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

Allergy, Asthma and Clinical Research Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Northwell Health System; 🇺🇸 Great Neck, New York, United States