The Effect of Per Oral Immunotherapy in Severe Milk, Peanut and Egg Allergy in Adults

NCT ID: NCT03361072

Last Updated: 2025-05-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-03

Study Completion Date

2023-03-11

Brief Summary

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The aim is to analyse the results of per oral immunotherapy treatment in severe milk, peanut or egg allergy in adults. This is the second part of the oral immunotherapy study in adults at Skin and Allergy Hospital. The diagnosis of food allergy is verified with positive history, skin prick tests, egg and milk allergen specific IgE (immunoglobulin E) antibodies. In addition, food allergy is verified with an open label (milk allergy) or blind (peanut and egg allergy) allergen specific challenge test. OIT (oral immunotherapy) is performed according to a detailed plan. Lung function parameters are followed before OIT and and a year after OIT.

Detailed Description

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30 patients with milk allergy (at least 18 year olds), 30 patients with peanut allergy and 30 patients with egg allergy are treated with OIT. The diagnosis of food allergy is verified with positive history, skin prick test, egg and milk allergen specific IgE antibodies. In addition, food allergy is verified with an open label (milk allergy) or blind (peanut and egg allergy) allergen specific challenge test. Quality of life, anxiety and patient history data is collected by questionnaires. All the patients undergo a spirometry with a bronchodilatator test, exhaled nitric oxide test and a methacholine challenge before and a year after oral immunotherapy. All the patients undergoing oral immunotherapy are prescribed with emergency medication such as antihistamine tablets, prednisolon tablets (40mg for three days in adults), epinephrine autoinjector (300 µg per dose) and salbutamol or terbutaline inhalator.

Conditions

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Food Allergy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective open label study on oral immunotherapy with either milk, or peanut or egg white food products.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Milk allergy

Milk oral immunotherapy intervention for milk allergy

Group Type EXPERIMENTAL

Oral immunotherapy

Intervention Type DIETARY_SUPPLEMENT

Milk, peanut or egg oral immunotherapy

Peanut allergy

Peanut oral immunotherapy intervention for peanut allergy

Group Type EXPERIMENTAL

Oral immunotherapy

Intervention Type DIETARY_SUPPLEMENT

Milk, peanut or egg oral immunotherapy

Egg allergy

Egg oral immunotherapy intervention for egg allergy

Group Type EXPERIMENTAL

Oral immunotherapy

Intervention Type DIETARY_SUPPLEMENT

Milk, peanut or egg oral immunotherapy

Interventions

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Oral immunotherapy

Milk, peanut or egg oral immunotherapy

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* severe milk, peanut or egg allergy verified with positive symptom history, skin prick tests and serum IgE tests and a challenge test

Exclusion Criteria

* instable cerebrovascular or heart disease, active autoimmune disease or cancer, or current use of betablockers.
* poorly controlled asthma or FEV1 \< 70% (FEV1\< -2SD)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Paula Kauppi, MD, PhD

MD, PhD, Chief Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paula Kauppi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HUS/486/2017

Identifier Type: -

Identifier Source: org_study_id

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