Safety of Oral Immunotherapy for Cow's Milk Allergy in School-aged Children

Tampere University Hospital28 enrolled

Overview

The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability.

Eligibility criteria: Age 6 - 16 yrs * IgE-mediated milk allergy * and milk provocation within 3 months prior to or an documented accidental milk contact with clear immediate symptoms Outcome measures: * number of patients with successful desensitization (195 - 200 ml milk per day) * number of patients with adverse events

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Milk Allergy Anaphylaxis

Interventions

milkDIETARY_SUPPLEMENT

milk for milk allergic children (1:25 dilution, whole milk)

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * IgE-mediated milk allergy * An immediately positive challenge test result to milk prior to inclusion Exclusion Criteria: * Not willing to participate

Locations (1)

Tampere University Hospital, Allergy Centre

Tampere, Finland

Outcomes

Primary Outcomes

Number of participants with adverse events as a measure of safety and tolerability

Time frame: 12 months

Secondary Outcomes

Number of participants drinking 2 dl/day of milk (success in desensitization)

Time frame: 12 months

Data from ClinicalTrials.gov

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