Overview

This trial is active, not recruiting.

Conditions milk allergy, anaphylaxis
Treatment milk
Phase phase 4
Sponsor Tampere University Hospital
Start date February 2008
End date December 2015
Trial size 28 participants
Trial identifier NCT01361347, PaassiltaM

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
rice/soy/oat "milk"drink, masked
milk milk allergy
milk for milk allergic children (1:25 dilution, whole milk)

Primary Outcomes

Measure
Number of participants with adverse events as a measure of safety and tolerability
time frame: 12 months

Secondary Outcomes

Measure
Number of participants drinking 2 dl/day of milk (success in desensitization)
time frame: 12 months

Eligibility Criteria

Male or female participants from 6 years up to 16 years old.

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

Additional Information

Official title Phase 4 Study: Milk Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
Principal investigator Marita Paassilta, MD, PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Tampere University Hospital.