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

Allergy Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01109966
• Other study ID #: CT0140PAICE
• Status: Terminated
• Phase: N/A
• First received: March 29, 2010
• Last updated: May 4, 2017
• Start date: June 2010
• Est. completion date: October 2012

Study information

• Verified date: May 2017
• Source: Nutricia Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 8 Months

Eligibility

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

Related Conditions & MeSH terms

• Allergy
• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Special Medical Food
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 Food
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.

Locations

Country	Name	City	State
France	l'hôpital Necker Enfants malades	Paris
Germany	Hospital Charité	Berlin
Germany	St.-Marien-Hospital	Bonn
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	Southampton General Hospital	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Countries where clinical trial is conducted

France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF.		2 years
Secondary	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