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.

Study Locations

  • Belgium
      • Namur, Belgium
        • Centre Hospitalier Régional
  • France
      • Paris, France
        • Necker Children's Hospital
  • Italy
      • Naples, Italy
        • University of Naples Federico II

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
Dietary supplement: 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

United Pharmaceuticals

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.

General Publications

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.

Clinical Trials on Cow Milk Allergy

Clinical Trials on Extensively Hydrolyzed formula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe