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

Anaphylaxis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361347
• Other study ID #: PaassiltaM
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2011
• Last updated: January 2, 2017
• Start date: February 2008
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

• IgE-mediated milk allergy

• An immediately positive challenge test result to milk prior to inclusion

Exclusion Criteria:

• Not willing to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaphylaxis
• Hypersensitivity
• Milk Allergy
• Milk Hypersensitivity

Intervention

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

Locations

Country	Name	City	State
Finland	Tampere University Hospital, Allergy Centre	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a measure of safety and tolerability		12 months	Yes
Secondary	Number of participants drinking 2 dl/day of milk (success in desensitization)		12 months	Yes