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

Condition(s) targeted: Allergy; Food Allergy

Intervention: Special Medical Food (Other); Special Medical Food (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Nutricia Liverpool

Official(s) and/or principal investigator(s):
Kirsten Beyer, MD, Principal Investigator, Affiliation: Hospital Charité

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.

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

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

Secondary outcome: 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

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.

Minimum age: N/A. Maximum age: 8 Months. Gender(s): Both.

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

l'hôpital Necker Enfants malades, Paris 75743, France; Not yet recruiting
Christophe Dupont, Prof., Email: christophe.dupont@nck.aphp.fr
Christophe Dupont, Prof. (MD), Principal Investigator

Hospital Charité, Berlin D-13353, Germany; Recruiting
Kirsten Beyer, PD Dr med, Phone: +49-(0)30-450 566037, Email: kirsten.beyer@charite.de
Kirsten Beyer, MD, Principal Investigator

St.-Marien-Hospital, Bonn 53115, Germany; Recruiting
Lars Lange, MD, Email: Lars.Lange@marien-hospital-bonn.de
Lars Lange, MD, Principal Investigator

Evelina Children's Hospital - St Thomas' Hospital, London SE1 7EH, United Kingdom; Recruiting
Adam Fox, MD, Email: adam.fox@gstt.nhs.uk
Adam Fox, MD, Principal Investigator

Newcastle general hospital, Newcastle upon Tyne NE4 6BE, United Kingdom; Recruiting
Gillian Vance, MD, Email: Gillian.Vance@nuth.nhs.uk
Gillian Vance, MD, Principal Investigator

Southampton General Hospital, Southampton, Hampshire SO16 6YD, United Kingdom; Recruiting
Mich Lajeunesse, MD, Email: mich.lajeunesse@soton.ac.uk
Mich Lajeunesse, MD, Principal Investigator
Louise Michaelis, MD, Sub-Investigator

David Hyde Allergy Clinic - St. Mary's hospital, Newport, Isle of Wight PO30 5TG, United Kingdom; Recruiting
Graham Roberts, MD, Email: g.c.roberts@soton.ac.uk
Graham Roberts, MD, Principal Investigator

Starting date: June 2010
Last updated: July 21, 2011