Elemental Formula Hypoallergenicity

Study Overview
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Brief Summary
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The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.

Official Title
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Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula

Conditions
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Food Hypersensitivity

Intervention / Treatment
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* Other: Amino Acid formula
* Other: Commercially available Amino Acid Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Born at term (>36 weeks gestation) 2 months to ≤12 years of age at enrollment Documented CMA within 6 months prior to enrollment Otherwise healthy Asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable Expected daily intake of at least 8 oz (240ml) of the study formula during the open challenge phase Having obtained his/her legal representative's informed consent Exclusion: Children consuming mother's milk at the time of inclusion and during the trial Any chromosomal or major congenital anomalies Any major gastrointestinal disease or abnormalities other than CMA Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay) Immunodeficiency Anti-histamine use in 7 days prior to the first food challenge (eyedrops are permitted) Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroid use are permitted) Unstable asthma Severe uncontrolled eczema Severe anaphylactic reaction to milk within the last 2 years Severe anaphylactic reaction to breastmilk within the last 2 years Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol Currently participating in another clinical trial.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Amino Acid formula<br> | Other: Amino Acid formula<br>* Amino Acid baby formula<br>|
| Active Comparator: Control formula<br>Commercially available Amino Acid infant formula | Other: Commercially available Amino Acid Formula<br>* Hypoallergenic Baby formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of allergic reactions | occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC) | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digestive Tolerance | gastrointestinal tolerance and formula intake recorded during the open challenge phase. | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cow milk allergy, CMA