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Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy

NCT02351531•United Pharmaceuticals

View on ClinicalTrials.gov

Summary

The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.

Eligibility

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•between 1 and 12 months old
•having a cow milk allergy confirmed by a positive double-blind food challenge performed in the last 3 months,
•whose parent(s) signed the informed consent form

Exclusion Criteria

•Infants mainly or exclusively breastfed,
•Infants having a weight at inclusion \< 2500g,
•Infants who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
•Infants fed an amino acid based formula
•Infants who had an anaphylactic reaction in the past,

Locations (3)

Centre Hospitalier Régional

Namur, Belgium

Necker Children's Hospital

Paris, France

University of Naples Federico II

Naples, Italy

Key Dates

Start Date

November 1, 2013

Primary Completion Date

December 1, 2014

Last Updated

January 30, 2015

Enrollment

ACTUAL participants

Conditions

Cow Milk Allergy

Interventions

Extensively Hydrolyzed formula

DIETARY_SUPPLEMENT

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

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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: January 30, 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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Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy

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