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

Not Applicable

Terminated

• Conditions: Allergy; Food Allergy
• Interventions: Other: Special Medical Food

• Registration Number: NCT01109966
• Lead Sponsor: Nutricia Research

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.

Study Timeline

• Study First Submitted: 2010-03-29
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Study Start: 2010-06
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amino acid based formula	Special Medical Food	Patients will be randomised to one of two arms: Group I: receiving a new amino-acid based formula Group II: receiving a standard AAF formula
New amino acid based formula	Special Medical Food	Patients will be randomised to one of two arms: Group I: receiving a new amino-acid based formula Group II: receiving a standard AAF formula

Primary Outcome Measures

Name	Time	Method
To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF.	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

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

Evelina Children's Hospital - St Thomas' Hospital; 🇬🇧 London, United Kingdom

Newcastle general hospital; 🇬🇧 Newcastle upon Tyne, United Kingdom

David Hyde Allergy Clinic - St. Mary's hospital; 🇬🇧 Newport, Isle of Wight, United Kingdom