Back to resultsCow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy (COMETE)
Primary Purpose
Cow Milk Allergy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Extensively Hydrolyzed formula
Sponsored by
About this trial
This is an interventional treatment trial for Cow Milk Allergy
Eligibility Criteria
Inclusion Criteria:
- between 1 and 12 months old
- having a cow milk allergy confirmed by a positive double-blind food challenge performed in the last 3 months,
- whose parent(s) signed the informed consent form
Exclusion Criteria:
- Infants mainly or exclusively breastfed,
- Infants having a weight at inclusion < 2500g,
- Infants who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
- Infants fed an amino acid based formula
- Infants who had an anaphylactic reaction in the past,
Sites / Locations
- Centre Hospitalier Régional
- Necker Children's Hospital
- University of Naples Federico II
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
New Thickened Extensively Hydrolyzed formula
Arm Description
Outcomes
Primary Outcome Measures
Number of patients dropped out for intolerance
Secondary Outcome Measures
Cow's milk protein hypersensitivity score
Growth (weight, height, head circumference)
Growth (weight, height, head circumference)
Full Information
NCT ID
NCT02351531
First Posted
January 21, 2015
Last Updated
January 27, 2015
Sponsor
United Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02351531
Brief Title
Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy
Acronym
COMETE
Official Title
Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow Milk Allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New Thickened Extensively Hydrolyzed formula
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Extensively Hydrolyzed formula
Primary Outcome Measure Information:
Title
Number of patients dropped out for intolerance
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Cow's milk protein hypersensitivity score
Time Frame
2 weeks
Title
Growth (weight, height, head circumference)
Time Frame
3 months
Title
Growth (weight, height, head circumference)
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
between 1 and 12 months old
having a cow milk allergy confirmed by a positive double-blind food challenge performed in the last 3 months,
whose parent(s) signed the informed consent form
Exclusion Criteria:
Infants mainly or exclusively breastfed,
Infants having a weight at inclusion < 2500g,
Infants who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
Infants fed an amino acid based formula
Infants who had an anaphylactic reaction in the past,
Facility Information:
Facility Name
Centre Hospitalier Régional
City
Namur
Country
Belgium
Facility Name
Necker Children's Hospital
City
Paris
Country
France
Facility Name
University of Naples Federico II
City
Naples
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
27430981
Citation
Dupont C, Bradatan E, Soulaines P, Nocerino R, Berni-Canani R. Tolerance and growth in children with cow's milk allergy fed a thickened extensively hydrolyzed casein-based formula. BMC Pediatr. 2016 Jul 18;16:96. doi: 10.1186/s12887-016-0637-3.
Results Reference
derived
Learn more about this trial
Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy
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