Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-06

Study Completion Date

2018-11-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Cow Milk Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test infant formula

Test non-commercial extensively hydrolyzed infant formula with HMOs

Group Type EXPERIMENTAL

Test extensively hydrolyzed formula

Intervention Type OTHER

extensively hydrolyzed formula with HMOs

Control infant formula

Control non-commercial extensively hydrolyzed infant formula without HMOs

Group Type ACTIVE_COMPARATOR

Control extensively hydrolyzed formula

Intervention Type OTHER

extensively hydrolyzed formula without HMOs

Interventions

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Test extensively hydrolyzed formula

extensively hydrolyzed formula with HMOs

Intervention Type OTHER

Control extensively hydrolyzed formula

extensively hydrolyzed formula without HMOs

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

2 Months

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes