Hypoallergenicity of a Hydrolyzed Protein Infant Formula

Study Overview
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Brief Summary
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Study to demonstrate hypoallergenicity of a hydrolysed protein infant formula in a population of children with confirmed cow's milk allergy.

Detailed Description
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The study consists of a double-blind, placebo-controlled food challenge, followed by a single arm open challenge.

Official Title
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Study to Assess Hypoallergenicity of a Hydrolysed Protein Formula in Children With Confirmed Cow's Milk Allergy

Conditions
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Cow's Milk Allergy

Intervention / Treatment
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* Other: Hydrolyzed protein infant formula
* Other: commercially available hypoallergenic infant formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants and children aged up to 3 years. Diagnosed with cow's milk allergy (or re-confirmed), within two months prior to the study (challenge day #1), by: Physician-supervised double-blind oral food challenge; or Physician-supervised open oral food challenge that elicited objective immediate allergic reactions; or Report of convincing allergic reaction to cow's milk or a milk-containing food product, in conjunction with presence of milk-specific serum Immunoglobuline E (IgE) level > 0.7 kilounit per liter (U/L) or by skin prick test (wheal size ≥ 3mm). Willing to switch to a different hypoallergenic formula On elimination diet (commercially available, hypoallergenic infant formula ) and free of clinical symptoms, or with controlled stable symptoms, for at least one week preceding the study (challenge day #1). Expected minimal consumption of 144ml of test product/day during the open challenge. Written informed consent provided by parents/guardians, according to local law. Exclusion Criteria: Infants/children who are more suitable to use AAF as first-line formula, including but not limited to those with high risk of anaphylaxis (prior history of anaphylaxis and currently not using eHF) or severe forms of non-IgE-mediated CMA such as eosinophilic oesophagitis, enteropathies, or Food Protein-Induced Enterocolitis Syndrome (FPIES). Diagnosis or known allergy to any of the ingredients in the test product. Congenital anomalies which will interfere with oral feeding or gastrointestinal tract, other chronic diseases (including but not limited to cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological and endocrine disease), major gastrointestinal disease/abnormalities, or any other medical condition that could interfere with the identification of allergic reactions. (Twin / triplet) sibling of an infant/child already participating in the study. Investigator's uncertainty about the willingness or ability of the subject and his/her parents to comply with the protocol requirements. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study. Employees and/or children/family members or relatives of employees of Nutricia Research or the participating study sites.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 3 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover assignment and an observational, single-arm, follow-up.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hydrolized protein formula<br>hydrolysed protein formula | Other: Hydrolyzed protein infant formula<br>* Hydrolyzed protein infant formula<br>|
| Placebo Comparator: Control formula<br>commercially available hypoallergenic infant formula | Other: commercially available hypoallergenic infant formula<br>* commercially available hypoallergenic infant formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoallergenicity | The percentage of children tolerating the formula tested by double-blind, placebo-controlled food challenge and a subsequent open challenge. | 25-35 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant formula, Hypoallergenicity