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

Tampere University Hospital

Status and phase: Completed; Phase 4

Conditions: Milk Allergy; Anaphylaxis

Treatments: Dietary Supplement: milk

Study type: Interventional

Funder types: Other

Identifiers

NCT01361347

PaassiltaM

Details and patient eligibility

About

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

Full description

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

Enrollment: 28 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• IgE-mediated milk allergy
• An immediately positive challenge test result to milk prior to inclusion

Exclusion criteria

• Not willing to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

rice/soy/oat "milk"drink, masked

Treatment:

Dietary Supplement: milk

milk

Experimental group

Description:

cow's milk

Treatment:

Dietary Supplement: milk