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Immunogenic Properties of Heated and Glycated Cow*s Milk Protein * Effect on Resolution of Cow*s Milk Allergy (iAGE study)

Immunogenic Properties of Heated and Glycated Cow*s Milk Protein * Effect on Resolution of Cow*s Milk Allergy (iAGE study) - iAGE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50280
Enrollment
200
Registered
2017-08-30
Start date
2018-02-15
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

koemelkallergie cow's milk allergy

Interventions

Treatment with heated-glycated cow's milk protein or placebo.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: * Age: 3 up to 36 months. * Children with a positive DBPCFC with CM. This is defined as a well-documented DBPCFC with objective symptoms

Exclusion criteria

Exclusion criteria: * Current participation or participation in the last 12 months in a medical scientific interventional study for food allergy and/or with an investigational new drug. * Clinically significant immunological, cardiovascular or malignant disease.* * Inability to discontinue antihistamines for skin testing and oral food challenges. * Caregiver not able to read and understand the Dutch language. * Caregiver not able or willing to comply with the study procedures.

Design outcomes

Primary

MeasureTime frame
Development of tolerance (time to or percentage)

Secondary

MeasureTime frame
Adverse events.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)