An Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy

Nutricia Research34 enrolled

Overview

The purpose of this study is to evaluate whether a new version of an amino acid based formula improves tolerance to milk in cow's milk allergic infants/young children.

Infants with CMA cannot tolerate proteins contained in milk, although they are able to tolerate amino acids which are the 'building blocks' of proteins. Unlike standard infant formulas which are made from milk proteins, amino acid formulas (AAF) are made from nonallergenic aminoacids plus all the other nutrients required to support growth and development.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Allergy Food Allergy

Interventions

Special Medical FoodOTHER

Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months. Infants should typically consume the following amounts of formula during the study \> 500mls/day up to 12 months of age \> 400mls/day between 12 and 18 months of age \> 300mls/day over 18 months of age.

Special Medical FoodOTHER

Eligibility

Sex: ALLMax age: 8 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Infants ≤ 8 months of age * Infants sensitised to cow's milk and diagnosed with IgE mediated cow's milk allergy confirmed by milk challenge or diagnosis of anaphylaxis to milk within the last 3 months Exclusion Criteria: * Infants less than 2500 g at birth * Infants less than 37 weeks gestation * Infants with severe concurrent illness * Use of anti- histamines, systemic corticosteroids, systemic antibiotics or anti-mycotic drugs, and immuno-modulatory drugs * Infants consuming less than 500ml per day of their usual formula at study entry * Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements * Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

Locations (7)

l'hôpital Necker Enfants malades

Paris, France

Hospital Charité

Berlin, Germany

St.-Marien-Hospital

Bonn, Germany

Southampton General Hospital

Southampton, Hampshire, United Kingdom

Outcomes

Primary Outcomes

To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF.

Time frame: 2 years

Secondary Outcomes

To evaluate maturation of the GI immune system in IgE mediated CMA To confirm that the test formula is effective in the dietary management of CMA To assess frequency of other allergies

Time frame: 2 years

Data from ClinicalTrials.gov

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