Back to resultsSafety of Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
Primary Purpose
Milk Allergy, Anaphylaxis
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
milk
Sponsored by
About this trial
This is an interventional treatment trial for Milk Allergy focused on measuring milk allergy, desensitization, anaphylaxis, school-age
Eligibility Criteria
Inclusion Criteria:
- IgE-mediated milk allergy
- An immediately positive challenge test result to milk prior to inclusion
Exclusion Criteria:
- Not willing to participate
Sites / Locations
- Tampere University Hospital, Allergy Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
milk
Arm Description
rice/soy/oat "milk"drink, masked
cow's milk
Outcomes
Primary Outcome Measures
Number of participants with adverse events as a measure of safety and tolerability
Secondary Outcome Measures
Number of participants drinking 2 dl/day of milk (success in desensitization)
Full Information
NCT ID
NCT01361347
First Posted
February 24, 2011
Last Updated
January 2, 2017
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01361347
Brief Title
Safety of Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
Official Title
Phase 4 Study: Milk Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Milk Allergy, Anaphylaxis
Keywords
milk allergy, desensitization, anaphylaxis, school-age
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
rice/soy/oat "milk"drink, masked
Arm Title
milk
Arm Type
Experimental
Arm Description
cow's milk
Intervention Type
Dietary Supplement
Intervention Name(s)
milk
Other Intervention Name(s)
milk allergy, desensitization
Intervention Description
milk for milk allergic children (1:25 dilution, whole milk)
Primary Outcome Measure Information:
Title
Number of participants with adverse events as a measure of safety and tolerability
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of participants drinking 2 dl/day of milk (success in desensitization)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
IgE-mediated milk allergy
An immediately positive challenge test result to milk prior to inclusion
Exclusion Criteria:
Not willing to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marita Paassilta, MD, PhD
Organizational Affiliation
Consultant Pediatric Allergist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital, Allergy Centre
City
Tampere
ZIP/Postal Code
FIN-33521
Country
Finland
12. IPD Sharing Statement
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Safety of Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
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