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

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

NCT01940068•United Pharmaceuticals

View on ClinicalTrials.gov

Summary

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;

Eligibility

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

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

Exclusion Criteria

•Exclusively breast fed infants
•non allergic digestive enteropathy

Locations (1)

Necker Children's Hospital

Paris, France

Key Dates

Start Date

March 1, 2011

Primary Completion Date

July 1, 2013

Completion Date

December 1, 2013

Last Updated

March 24, 2015

Enrollment

ACTUAL participants

Conditions

Cow Milk Allergy

Interventions

Amino acid based formula

DIETARY_SUPPLEMENT

Clinical Versus Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy

NCT05785299

Cow Milk AllergyFood Allergy

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ACTIVE_NOT_RECRUITING

Detection of Metabolite Biomarkers for the Early Diagnosis and Prognosis of Cow's Milk Allergy in Children

NCT04249973

Cow Milk AllergyFood Allergy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Clinical Versus Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy

Detection of Metabolite Biomarkers for the Early Diagnosis and Prognosis of Cow's Milk Allergy in Children

Epigenetic Effects in Children With Cow's Milk Allergy Treated With Different Formulas

The Frequency of Beef Allergy in Children With Cow Milk Allergy

Synbiotic Extensively Hydrolysed Feed Study

Growth and Plasma Amino Acids in Infants With CMPA and Treated With a Newly Innovated Amino Acid Formula