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

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;

Completed

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Key information

Conditions

Cow Milk Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

2 week–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necker Children's Hospital

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amino acid based formula

Dietary Supplement

Primary outcomes

Number of withdrawal for intolerance

Time frame: 1 month

Sponsors and collaborators

Lead sponsor

United Pharmaceuticals

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Sep 11, 2013
Registry last updated: Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed