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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02351531

Acronym

COMETE

Enrollment

Registered

2015-01-30

Start date

2013-11-30

Completion date

Unknown

Last updated

2015-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow Milk Allergy

Brief summary

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

Interventions

DIETARY_SUPPLEMENTExtensively Hydrolyzed formula

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 12 Months

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,

Design outcomes

Primary

Measure	Time frame
Number of patients dropped out for intolerance	2 weeks

Secondary

Measure	Time frame
Cow's milk protein hypersensitivity score	2 weeks
Growth (weight, height, head circumference)	3 months

Countries

Belgium, France, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026