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

Food Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03361072
• Other study ID #: HUS/486/2017
• Status: Completed
• Phase: N/A
• Start date: August 3, 2017
• Est. completion date: March 11, 2023

Study information

• Verified date: March 2023
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 11, 2023
• Est. primary completion date: March 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Egg Hypersensitivity
• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Dietary Supplement:
• Oral immunotherapy
Milk, peanut or egg oral immunotherapy

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-related adverse events	Follow-up of safety of OIT	1 year, through study completion
Other	Decrease in allergen specific IgE values	Decrease in allergen specific IgE values	1 year, through study completion
Primary	Desensitisation	Increase in tolerated dose of food compared to the pre-OIT, number of participants	1 year, through study completion
Secondary	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	1 year, through study completion