Back to resultsAn Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy
Primary Purpose
Allergy, Food Allergy
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Special Medical Food
Special Medical Food
Sponsored by
About this trial
This is an interventional supportive care trial for Allergy focused on measuring Allergy, Cow's Milk, Infants, Food Allergy
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
Sites / Locations
- l'hôpital Necker Enfants malades
- Hospital Charité
- St.-Marien-Hospital
- Southampton General Hospital
- David Hyde Allergy Clinic - St. Mary's hospital
- Evelina Children's Hospital - St Thomas' Hospital
- Newcastle general hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Amino acid based formula
New amino acid based formula
Arm Description
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
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
Outcomes
Primary Outcome Measures
To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01109966
Brief Title
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
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Study Start Date
June 2010 (Actual)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutricia Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy, Food Allergy
Keywords
Allergy, Cow's Milk, Infants, Food Allergy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amino acid based formula
Arm Type
Active Comparator
Arm Description
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
Arm Title
New amino acid based formula
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Special Medical Food
Other Intervention Name(s)
Amino acid based formula, Neocate LCP
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Special Medical Food
Other Intervention Name(s)
Amino acid based formula
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Beyer, MD
Organizational Affiliation
Hospital Charité
Official's Role
Principal Investigator
Facility Information:
Facility Name
l'hôpital Necker Enfants malades
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
Hospital Charité
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
St.-Marien-Hospital
City
Bonn
ZIP/Postal Code
53115
Country
Germany
Facility Name
Southampton General Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
David Hyde Allergy Clinic - St. Mary's hospital
City
Newport
State/Province
Isle of Wight
ZIP/Postal Code
PO30 5TG
Country
United Kingdom
Facility Name
Evelina Children's Hospital - St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Newcastle general hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33006765
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.
Results Reference
derived
Learn more about this trial
An Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy
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