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

Phase 4 Study: Milk Oral Immunotherapy for Cow's Milk Allergy in School-aged Children

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01361347

Enrollment

Registered

2011-05-26

Start date

2008-02-29

Completion date

2016-12-31

Last updated

2017-01-04

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

Conditions

Anaphylaxis, Milk Allergy

Keywords

milk allergy, desensitization, anaphylaxis, school-age

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

Interventions

DIETARY_SUPPLEMENTmilk

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Years to 16 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026