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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)

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ClinicalTrials.gov Identifier: NCT02351531
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : January 30, 2015
Sponsor:
Information provided by (Responsible Party):
United Pharmaceuticals

Brief Summary:
The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.

Condition or disease Intervention/treatment Phase
Cow Milk Allergy Dietary Supplement: Extensively Hydrolyzed formula Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy
Study Start Date : November 2013
Actual Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: New Thickened Extensively Hydrolyzed formula Dietary Supplement: Extensively Hydrolyzed formula



Primary Outcome Measures :
  1. Number of patients dropped out for intolerance [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Cow's milk protein hypersensitivity score [ Time Frame: 2 weeks ]
  2. Growth (weight, height, head circumference) [ Time Frame: 3 months ]
  3. Growth (weight, height, head circumference) [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351531


Locations
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Belgium
Centre Hospitalier Régional
Namur, Belgium
France
Necker Children's Hospital
Paris, France
Italy
University of Naples Federico II
Naples, Italy
Sponsors and Collaborators
United Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: United Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02351531     History of Changes
Other Study ID Numbers: UP-2013-02
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: January 30, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
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Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate