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

February 24, 2011
June 10, 2011
February 2008
December 2012   (final data collection date for primary outcome measure)
Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01361347 on ClinicalTrials.gov Archive Site
Number of participants drinking 2 dl/day of milk (success in desensitization) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Milk Allergy
  • Anaphylaxis
Dietary Supplement: milk
milk for milk allergic children (1:25 dilution, whole milk)
Other Names:
  • milk allergy
  • desensitization
Experimental: placebo
rice/soy/oat drink, masked
Intervention: Dietary Supplement: milk
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
28
December 2014
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Not willing to participate
Both
6 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01361347
PaassiltaM
Yes
Paassilta M, Tampere University Hospital
Tampere University Hospital
Not Provided
Principal Investigator: Marita Paassilta, MD, PhD Consultant Pediatric Allergist
Tampere University Hospital
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP