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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01361347
First received: February 24, 2011
Last updated: June 10, 2011
Last verified: May 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Milk Allergy
Anaphylaxis
 Dietary Supplement: milk
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 4 Study: Milk Oral Immunotherapy for Cow's Milk Allergy in School-aged Children

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants drinking 2 dl/day of milk (success in desensitization) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 28
Study Start Date: February 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: placebo
rice/soy/oat drink, masked
 Dietary Supplement: milk
milk for milk allergic children (1:25 dilution, whole milk)
Other Names:
  • milk allergy
  • desensitization

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
  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not willing to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361347

Locations
Finland
Tampere University Hospital, Allergy Centre
Tampere, Finland, FIN-33521
Sponsors and Collaborators
Tampere University Hospital
Investigators
Principal Investigator: Marita Paassilta, MD, PhD Consultant Pediatric Allergist
  More Information

No publications provided

Responsible Party: Paassilta M, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01361347     History of Changes
Other Study ID Numbers: PaassiltaM
Study First Received: February 24, 2011
Last Updated: June 10, 2011
Health Authority: Finland: Ethics Committee

Keywords provided by Tampere University Hospital:
milk allergy
desensitization
anaphylaxis
school-age

Additional relevant MeSH terms:
Hypersensitivity
Anaphylaxis
Milk Hypersensitivity
 Immune System Diseases
Hypersensitivity, Immediate
Food Hypersensitivity

ClinicalTrials.gov processed this record on May 16, 2013