Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

Cow Milk Allergy Clinical Trial

Official title:

Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236207
• Other study ID #: 16.16.CLI
• Status: Completed
• Phase: N/A
• Start date: July 6, 2017
• Est. completion date: November 6, 2018

Study information

• Verified date: January 2019
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 6, 2018
• Est. primary completion date: November 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Cow Milk Allergy
• Milk Hypersensitivity

Intervention

Other:
• Test extensively hydrolyzed formula
extensively hydrolyzed formula with HMOs
• Control extensively hydrolyzed formula
extensively hydrolyzed formula without HMOs

Locations

Country	Name	City	State
United States	Breathe America	Albuquerque	New Mexico
United States	Northwell Health System	Great Neck	New York
United States	Houston Clinical Research Associates	Houston	Texas
United States	Hoag Medical Group	Huntington Beach	California
United States	Memphis & Shelby County Pediatrics	Memphis	Tennessee
United States	Stanford University	Mountain View	California
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Allergy, Asthma and Clinical Research Center	Oklahoma City	Oklahoma
United States	Carolina ENT	Orangeburg	South Carolina
United States	Clinical Research Institute	Plymouth	Minnesota
United States	Midwest Clinical Research	Saint Louis	Missouri
United States	Allergy Asthma Research Institute	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	stool characteristics	collected on daily diaries	1 week
Secondary	formula intake	amount of formula ingested daily	1 week
Secondary	adverse events	adverse events as reported by caregivers	1 week