Tolerance of Infants With Cow's Milk Protein Allergy to Extensively Hydrolyzed Rice Protein or Casein Infant Formulas

Study Overview
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Brief Summary
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The objective of this double blinded randomized study is to assess the tolerance of two extensively protein hydrolyzed infant formulas, one based on rice protein and the other one on casein, at introduction, and after 3 months of consumption, and their efficacy on growth and on the reduction of allergy symptoms through a 3 months consumption period.

Official Title
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Tolerancia a 2 fórmulas de Leche Infantil Altamente Hidrolizadas en Base a proteínas de Arroz y a caseína en niños Con Alergia a Las proteínas de Leche de Vaca

Conditions
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Cow Milk Protein Sensitivity, Tolerance, Growth Failure

Intervention / Treatment
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* Other: Damira/Celia peptide hydrolyzed casein
* Other: Picot riz/Celia rice/Sanutri arroz


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full term healthy newborns (37-42 Weeks gestation) Weight at birth ≥ 2500 g Aged between birth to 9 months Symptoms of allergy (Skin or digetive) Suspicion of cow milk protein allergy Infants whose parents/caregivers/legal guardians have the ability to understand and comply with the requirements of the study Infants whose parents/caregivers/legal guardians gave their written informed consent to the infant's participation in the study Exclusion Criteria: Children who have returned to breastfeeding Presence of any condition, that, in the opinion of the investigator is a contra-indication to the particpation of the infant in the study In the past 15 days, treatment or medication likely to : induce confusion in the allergy tets (ex. : Skin Prick Test) and / or mask the symptoms of an allergic reaction (Anti-allergy medications ; anti-histaminic, anti-leucotrienes, corticosteroids, …) Newbonrs presenting a chronic or a genetic malformation, or a chromosomal or other disease, that in the opinion of the investigator could mask the study results Children who show signs of malnutrition, or prolonged diarrhea Children whose parents show no willingness to comply with study requirements Consumption of soya protein based, hydrolyzed protein or elemental (amino acid) formula for more than 21 days before inclusion, unless the skin prick test to cow's milk protein is positive, and the IgE level indicates the existence of IgE mediated allergy to cow's milk protein.

Ages Eligible for Study
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Maximum Age: 9 Months

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Damira/Celia peptide hydrolyzed casein<br>Extensively Hydrolyzed (EH)casein infant formula | Other: Damira/Celia peptide hydrolyzed casein<br> <br> |
| Experimental: Picot riz/Celia rice/Sanutri arroz<br>Picot riz/Celia rice/Sanutri arroz Extensively Hydrolyzed (EH) rice protein infant formula | Other: Picot riz/Celia rice/Sanutri arroz<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of infants who tolerate either the rice hydrolyzed protein infant formula or a hydrolyzed casein infant formula after 24h consumption. | Tolerance is absence of clinical signs. | 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectivness of the hydrolyzed protein formulas in terms of growth and allergy symptoms improvement. | Evaluate during 3 months of consumption the effectiveness of the formulas, in terms of : infant growth, through anthropometric measures (body weight, length and head circumference) allergy symptoms, through the improvement of the allergy symptoms. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allergy, Cow's milk protein, Tolerance, Efficacy, Infants' growth