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

Phase 4

Completed

• Conditions: Milk Allergy; Anaphylaxis
• Interventions: Dietary Supplement: milk

• Registration Number: NCT01361347
• Lead Sponsor: Tampere University Hospital

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-05-25
• Study First Posted: 2011-05-26
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-02
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

Exclusion Criteria

• Not willing to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
milk	milk	cow's milk
placebo	milk	rice/soy/oat "milk"drink, masked

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability	12 months

Secondary Outcome Measures

Name	Time	Method
Number of participants drinking 2 dl/day of milk (success in desensitization)	12 months

Trial Locations

Locations (1)

Tampere University Hospital, Allergy Centre; 🇫🇮 Tampere, Finland