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

NCT01822353 | Completed Results

• 1 other identifier: HUS21813030112
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Food Allergy

Keywords

food allergy; milk allergy; egg allergy; nut allergy

Outcome Measures

Primary Outcomes (1)

• Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy

  Number of the patients that achieve higher tolerance of allergen with immunotherapy in one year than the measured baseline allergen challenge shows.

  One year

Secondary Outcomes (3)

• Effect of Therapy on Lung Function.

  One year

• Does Oral Immunotherapy Change Bronchial Hyperreactivity?

  One year

• Does the Oral Immunotherapy Have en Effect on Airway Inflammation?

  One year

Other Outcomes (2)

• Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.

  One year

• Effect of Treatment on Quality of Life

  one year

Study Arms (3)

Milk allergy

EXPERIMENTAL

Dietary supplement, milk in increasing dosages, delivered daily and orally.

Dietary Supplement: Dietary supplement

Egg allergy

EXPERIMENTAL

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

Dietary Supplement: Dietary supplement

Nut allergy

EXPERIMENTAL

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

Dietary Supplement: Dietary supplement

Interventions

Dietary supplement DIETARY_SUPPLEMENT

Milk, egg or nut oral immunotherapy

Also known as: Milk, Egg protein, Nut cream

Egg allergy; Milk allergy; Nut allergy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• severe IgE-mediated milk allergy or
• severe IgE-mediated egg allergy or
• severe IgE-mediated nut allergy or
• years

You may not qualify if:

• instable cerebrovascular or heart disease
• active autoimmune disease or cancer
• use of betablocker agents
• poorly controlled asthma
• FEV1 \< 70% of the predicted

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

MeSH Terms

Conditions

Food Hypersensitivity; Milk Hypersensitivity; Egg Hypersensitivity; Nut Hypersensitivity

Interventions

Dietary Supplements; Milk; Egg Proteins

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Dairy Products; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Paula Kauppi, Chief Specialist
• Organization: Helsinki University Hospital, Helsinki, Finland

paula.kauppi@hus.fi

+358504286802

Study Officials

• Mika J Mäkelä, MD, PhD

  Helsinki University Central Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: April 2, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 11, 2021
• Results First Posted: August 9, 2019

Record last verified: 2021-01

Locations

FI (1)