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

NCT ID: NCT01361347

Last Updated: 2017-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Milk Allergy Anaphylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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placebo

rice/soy/oat "milk"drink, masked

Group Type PLACEBO_COMPARATOR

milk

Intervention Type DIETARY_SUPPLEMENT

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

milk

cow's milk

Group Type EXPERIMENTAL

milk

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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milk

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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milk allergy desensitization

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not willing to participate
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marita Paassilta

MD, PhD, Paediatric Allergist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marita Paassilta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Consultant Pediatric Allergist

Locations

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Tampere University Hospital, Allergy Centre

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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PaassiltaM

Identifier Type: -

Identifier Source: org_study_id

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