search
Back to results

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

Primary Purpose

Food Allergy

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Oral immunotherapy
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Allergy focused on measuring oral immunotherapy, milk, peanut, egg, adult

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Helsinki University Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Milk allergy

Peanut allergy

Egg allergy

Arm Description

Milk oral immunotherapy intervention for milk allergy

Peanut oral immunotherapy intervention for peanut allergy

Egg oral immunotherapy intervention for egg allergy

Outcomes

Primary Outcome Measures

Desensitisation
Increase in tolerated dose of food compared to the pre-OIT, number of participants

Secondary Outcome Measures

Decrease in worries associated with food allergy
Quality of life and reported concerns and worries associated with food allergy using a VAS scale (visual analogue scale) from 0 (no worries) to 100 mm (maximal worries) before OIT and at one year after OIT

Full Information

First Posted
August 11, 2017
Last Updated
March 11, 2023
Sponsor
Helsinki University Central Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03361072
Brief Title
The Effect of Per Oral Immunotherapy in Severe Milk, Peanut and Egg Allergy in Adults
Official Title
The Effect of Per Oral Immunotherapy Treatment in Severe IgE Mediated Milk, Peanut and Egg Allergy in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 3, 2017 (Actual)
Primary Completion Date
March 11, 2023 (Actual)
Study Completion Date
March 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy
Keywords
oral immunotherapy, milk, peanut, egg, adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective open label study on oral immunotherapy with either milk, or peanut or egg white food products.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Milk allergy
Arm Type
Experimental
Arm Description
Milk oral immunotherapy intervention for milk allergy
Arm Title
Peanut allergy
Arm Type
Experimental
Arm Description
Peanut oral immunotherapy intervention for peanut allergy
Arm Title
Egg allergy
Arm Type
Experimental
Arm Description
Egg oral immunotherapy intervention for egg allergy
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral immunotherapy
Intervention Description
Milk, peanut or egg oral immunotherapy
Primary Outcome Measure Information:
Title
Desensitisation
Description
Increase in tolerated dose of food compared to the pre-OIT, number of participants
Time Frame
1 year, through study completion
Secondary Outcome Measure Information:
Title
Decrease in worries associated with food allergy
Description
Quality of life and reported concerns and worries associated with food allergy using a VAS scale (visual analogue scale) from 0 (no worries) to 100 mm (maximal worries) before OIT and at one year after OIT
Time Frame
1 year, through study completion
Other Pre-specified Outcome Measures:
Title
Number of participants with treatment-related adverse events
Description
Follow-up of safety of OIT
Time Frame
1 year, through study completion
Title
Decrease in allergen specific IgE values
Description
Decrease in allergen specific IgE values
Time Frame
1 year, through study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Kauppi, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs