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Food Allergy | The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk, and Nut Allergy in Adults

Food Allergy research study

What is the primary objective of this study?

In Finland, the estimated prevalence of physician-diagnosed food allergy in 1-4 year old children is 9%, and the most common allergen is milk. The overall food allergy has been reported to be 3.7%. Hen's egg allergy is among the most common food allergies in childhood. In addition, it predicts later development of allergic disease such as asthma. Most of the egg and milk allergy is transient and disappears in childhood. Currently, the standard of care for food allergy includes strict allergen avoidance. However, oral immunotherapy has been under investigation in children milk, egg, and wheat allergy. Previously, induction of clinical egg tolerance has been reported with egg oral immunotherapy in children aged from 3 to 13 years. In adults, strict avoidance is still the standard care but there is also growing interest in treatment of severe food allergy with oral immunotherapy or anti-IgE. The investigators aim to analyse the results of per oral immunotherapy treatment in severe IgE-mediated egg, milk, and nut allergy in adults. Could severe egg, milk and nut allergy be treated with oral immunotherapy treatment in stead of total allergen avoidance and could desensitization thus be achieved?

Who is eligible to participate?

Inclusion Criteria: - severe IgE-mediated milk allergy or - severe IgE-mediated egg allergy or - severe IgE-mediated nut allergy or - 18-50 years Exclusion Criteria: - instable cerebrovascular or heart disease - active autoimmune disease or cancer - use of betablocker agents - poorly controlled asthma - FEV1 < 70% of the predicted

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Food Allergy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:Dietary supplementMilk, egg or nut oral immunotherapy

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Milk allergyDietary supplement, milk in increasing dosages, delivered daily and orally.

Egg allergyDietary supplement, egg protein given in increasing dosages, delivered daily and orally.

Nut allergyDietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.

Study Status

Active, not recruiting

Start Date: January 2013

Completed Date: December 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Number of the patients that achieve higher tolerance of allergen with immunotherapy than the measured baseline allergen challenge shows?

Secondary Outcome: Effect of therapy on lung function.

Study sponsors, principal investigator, and references

Principal Investigator: Mika J Mäkelä, MD, PhD

Lead Sponsor: Helsinki University Central Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01822353

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