Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula

Study Overview
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Brief Summary
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The aim of this study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a double blind placebo controlled food challenge, followed by a 3-month open feeding period.

Official Title
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Evaluation of the Hypoallergenicity of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow's Milk Protein Allergy

Conditions
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Cow Milk Allergy

Intervention / Treatment
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* Dietary Supplement: Extensively Hydrolyzed formula
* Dietary Supplement: Amino acid formula


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Infants: with cow's milk allergy confirmed by a double-blind food challenge performed in the last 2 months, successfully fed an eviction diet for at least 2 weeks Main Non-inclusion Criteria: Infants: fed with an extensively hydrolyzed formula with no improvement of the symptoms, who refused to drink an extensively hydrolyzed formula anytime prior to inclusion, fed a vegetable based formula fed an amino acid based formula or who should be fed with an amino acid based formula according to recommendations who had an anaphylactic reaction in the past

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 36 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extensively hydrolyzed formula<br>Feeding extensively hydrolyzed formula | Dietary Supplement: Extensively Hydrolyzed formula<br> <br> |
| Placebo Comparator: Amino acid formula<br>Feeding amino acid formula | Dietary Supplement: Amino acid formula<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of infants tolerating the formula during a double blind placebo controlled food challenge |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regurgitation assessed through Vandenplas score |  | 7, 45 and 90 days | 
| Vomiting (weekly frequency) |  | 7, 45 and 90 days | 
| Abdominal pain (severity on a 4 level scale) |  | 7, 45 and 90 days | 
| Bloating and gas (severity on a 4 level scale) |  | 7, 45 and 90 days | 
| Stool consistency assessed through Bristol Stools Form Scale |  | 7, 45 and 90 days | 
| Sleeping time over 24h |  | 7, 45 and 90 days | 
| Stool frequency over 72h |  | 7, 45 and 90 days | 
| Blood in stools (presence/absence) |  | 7, 45 and 90 days | 
| Duration of crying over 24h |  | 7, 45 and 90 days | 
| Respiratory symptoms (severity on a 4 level scale) |  | 7, 45 and 90 days | 
| Urticaria (presence/absence) |  | 7, 45 and 90 days | 
| Eczema assessed through SCORAD |  | 7, 45 and 90 days | 
| Weight expressed in z scores according to the WHO Child Growth Standards |  | 45 and 90 days | 
| Height expressed in z scores according to the WHO Child Growth Standards |  | 45 and 90 days | 
| BMI expressed in z scores according to the WHO Child Growth Standards |  | 45 and 90 days | 
| Head circumference expressed in z scores according to the WHO Child Growth Standards |  | 45 and 90 days | 
| Number of patients with treatment emergent Adverse Events |  | 7, 45 and 90 days |