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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by Nutricia Liverpool
Sponsor:
Information provided by:
Nutricia Liverpool
ClinicalTrials.gov Identifier:
NCT01109966
First received: March 29, 2010
Last updated: July 21, 2011
Last verified: July 2011

March 29, 2010
July 21, 2011
June 2010
November 2013   (final data collection date for primary outcome measure)
To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01109966 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy
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)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Allergy
  • Food Allergy
  • 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.

    Other Name: Amino acid based formula, Neocate LCP
  • 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.

    Other Name: Amino acid based formula
  • Active Comparator: Amino acid based formula

    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

    Intervention: Other: Special Medical Food
  • Active Comparator: New amino acid based formula

    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

    Intervention: Other: Special Medical Food
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
228
November 2014
November 2013   (final data collection date for primary outcome measure)

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
Both
up to 8 Months
No
United Kingdom,   Germany,   France
 
NCT01109966
CT0140PAICE
No
Research and Development, Nutricia Liverpool
Nutricia Liverpool
Not Provided
Principal Investigator: Kirsten Beyer, MD Hospital Charité
Nutricia Liverpool
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP