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

United Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Cow Milk Allergy

Treatments: Dietary Supplement: Extensively Hydrolyzed formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT02351531

UP-2013-02

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 1 to 12 months old

Volunteers: No 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,

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

New Thickened Extensively Hydrolyzed formula

Experimental group

Treatment:

Dietary Supplement: Extensively Hydrolyzed formula