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NCT02351531 Clinical Trial

Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy

Cow Milk Allergy Clinical Trial

— COMETE  

Official title:
Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02351531
Other study ID # UP-2013-02
Secondary ID
Status Completed
Phase Phase 3
First received January 21, 2015
Last updated January 27, 2015
Start date November 2013

Study information
Verified date January 2015
Source United Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santéBelgium: Ethics CommitteeItaly: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 12 Months
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Extensively Hydrolyzed formula

Locations
Country Name City State
Belgium Centre Hospitalier Régional Namur
France Necker Children's Hospital Paris
Italy University of Naples Federico II Naples

Sponsors (1)
Lead Sponsor Collaborator
United Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  France,  Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients dropped out for intolerance 2 weeks Yes
Secondary Cow's milk protein hypersensitivity score 2 weeks No
Secondary Growth (weight, height, head circumference) 3 months No
Secondary Growth (weight, height, head circumference) 4 months No
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