A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates

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

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to evaluate the impact of a new Amino-acid based formula on allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to extensively hydrolysed formulas;

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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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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New Thickened Amino acid based formula

Group Type EXPERIMENTAL

Amino acid based formula

Intervention Type DIETARY_SUPPLEMENT

Amino acid based formula

Group Type ACTIVE_COMPARATOR

Amino acid based formula

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Amino acid based formula

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* less than 18 months old
* with a proven cow's milk protein allergy by a double blind placebo controlled food challenge or a positive Skin prick test (\>=6mm) or specific immunoglobulin E \>= 5 kilo-unit/L or combination
* still symptomatic while fed an extensively hydrolysed formula