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Cow 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
United Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cow Milk Allergy

Eligibility Criteria

1 Month - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

First Posted
January 21, 2015
Last Updated
January 27, 2015
Sponsor
United Pharmaceuticals
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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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