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Clinical Trials/NCT01361347
NCT01361347CompletedPhase 4

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

Tampere University Hospital2 sites in 1 country28 target enrollmentStarted: February 2008Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
28
Locations
2
Primary Endpoint
Number of participants with adverse events as a measure of safety and tolerability
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
6 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •Not willing to participate

Outcomes

Primary Outcomes

Number of participants with adverse events as a measure of safety and tolerability

Time Frame: 12 months

Secondary Outcomes

  • Number of participants drinking 2 dl/day of milk (success in desensitization)(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marita Paassilta

MD, PhD, Paediatric Allergist

Tampere University Hospital

Study Sites (2)

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