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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Milk Hypersensitivity
Anaphylaxis
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on September 30, 2014