Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula

Nestlé

Status: Completed

Conditions: Cow's Milk Allergy

Treatments: Other: Control extensively hydrolyzed formula; Other: Test extensively hydrolyzed formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT02450643

14.24.CLI

Details and patient eligibility

About

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.

Enrollment: 83 estimated patients

Sex: All

Ages: 2 months to 4 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

83 participants in 2 patient groups

Test then Control

Active Comparator group

Description:

Subjects will perform a DBPCFC with the Test formula followed by the Control formula

Treatment:

Other: Control extensively hydrolyzed formula

Other: Test extensively hydrolyzed formula

Control then Test

Active Comparator group

Description:

Subjects will perform a DBPCFC with the Control formula followed by the Test formula

Treatment:

Other: Control extensively hydrolyzed formula

Other: Test extensively hydrolyzed formula