A Prospective, Double Blind Randomised Controlled Trial to Evaluate the Immunological Benefits and Clinical Effects of an Elimination Diet Using an Amino Acid Based Formula (AAF)

Nutricia Research7 sites in 3 countries34 target enrollmentJune 2010

ConditionsAllergy Food Allergy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Allergy
Sponsor: Nutricia Research
Enrollment: 34
Locations: 7
Primary Endpoint: To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF.
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

October 2012

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nutricia Research

Responsible Party

Sponsor

Eligibility Criteria

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

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(2 years)