Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy (COMETE)
January 27, 2015 updated by: United Pharmaceuticals
The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: New Thickened Extensively Hydrolyzed formula
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of patients dropped out for intolerance
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Growth (weight, height, head circumference)
Time Frame: 3 months
|
3 months
|
|
Cow's milk protein hypersensitivity score
Time Frame: 2 weeks
|
2 weeks
|
|
Growth (weight, height, head circumference)
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
January 21, 2015
First Submitted That Met QC Criteria
January 27, 2015
First Posted (Estimate)
January 30, 2015
Study Record Updates
Last Update Posted (Estimate)
January 30, 2015
Last Update Submitted That Met QC Criteria
January 27, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UP-2013-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.