Clinical trial NCT01109966: An Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Allergy
Food Allergy
Keywords: Allergy
Cow's Milk
Infants
Food Allergy
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2010-04-23
Enrollment: 34
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF.
timeFrame: 2 years
Secondary outcomes:
measure: 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
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: l'hôpital Necker Enfants malades
city: Berlin
country: Germany
facility: Hospital Charité
city: Bonn
country: Germany
facility: St.-Marien-Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: Newport
country: United Kingdom
facility: David Hyde Allergy Clinic - St. Mary's hospital
state: Isle of Wight
city: London
country: United Kingdom
facility: Evelina Children's Hospital - St Thomas' Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle general hospital
Study officials:
affiliation: Hospital Charité
name: Kirsten Beyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.