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

NCT03361072 | Completed Results

• 1 other identifier: HUS/486/2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Food Allergy

Keywords

oral immunotherapy; milk; peanut; egg; adult

Outcome Measures

Primary Outcomes (1)

• Desensitisation

  Increase in tolerated dose (that is no symptoms if accidental exposure) of food compared to the pre-OIT, number of participants

  1 year, through study completion

Secondary Outcomes (1)

• Worries Associated With Food Allergy

  1 year, through study completion

Other Outcomes (2)

• Number of Participants With Treatment-related Adverse Events

  1 year, through study completion

• Decrease in Allergen Specific IgE Values

  1 year, through study completion

Study Arms (3)

Milk allergy

EXPERIMENTAL

Milk oral immunotherapy intervention for milk allergy

Dietary Supplement: Oral immunotherapy

Peanut allergy

EXPERIMENTAL

Peanut oral immunotherapy intervention for peanut allergy

Dietary Supplement: Oral immunotherapy

Egg allergy

EXPERIMENTAL

Egg oral immunotherapy intervention for egg allergy

Dietary Supplement: Oral immunotherapy

Interventions

Oral immunotherapy DIETARY_SUPPLEMENT

Milk, peanut or egg oral immunotherapy

Egg allergy; Milk allergy; Peanut allergy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Results Point of Contact

• Title: Dr Paula Kauppi
• Organization: Helsinki University Hospital

paula.kauppi@hus.fi

+358504286802

Study Officials

• Paula Kauppi, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: 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, Chief Specialist

Model Details: Prospective open label study on oral immunotherapy with either milk, or peanut or egg white food products.

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: December 4, 2017
• Study Start: August 3, 2017
• Primary Completion: March 11, 2023
• Study Completion: March 11, 2023
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-05

Locations

FI (1)