NCT03361072

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

Completed NA Results posted Last updated 9 May 2025

What this trial tests

NA trial testing Oral immunotherapy in Food Allergy in 30 participants. Completed in 11 March 2023.

Timeline

3 August 2017

Primary endpoint
11 March 2023

11 March 2023

Quick facts

Lead sponsor	Helsinki University Central Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	3 August 2017
Primary completion	11 March 2023
Estimated completion	11 March 2023
Sites	1 location across Finland

Drugs / interventions tested

• Oral immunotherapy

Conditions studied

• Food Allergy — all drugs for Food Allergy →

Sponsor

Helsinki University Central Hospital

Who can join

Adults 18 to 70, any sex, with Food Allergy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Desensitisation Primary · 1 year, through study completion

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

Group	Value	95% CI
Milk Allergy	7
Peanut Allergy	5
Egg Allergy	2

Worries Associated With Food Allergy Secondary · 1 year, through study completion

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

Before OIT (VAS)

Group	Value	95% CI
Milk Allergy	77.7	± 19.2
Peanut Allergy	69.7	± 12.4
Egg Allergy	61.0	± 13.0

After OIT, at one year (VAS)

Group	Value	95% CI
Milk Allergy	79.00	± 5.6
Peanut Allergy	39.5	± 19.1
Egg Allergy	25.0	± 0.0

Number of Participants With Treatment-related Adverse Events Secondary · 1 year, through study completion

Follow-up of safety of OIT, Number of participants with treatment-related adverse events

Group	Value	95% CI
Milk Allergy	12
Peanut Allergy	14
Egg Allergy	4

Decrease in Allergen Specific IgE Values Secondary · 1 year, through study completion

Allergen specific IgE values before OIT and after OIT (kU/l)

IgE pre OIT

Group	Value	95% CI
Milk Allergy	100.7	± 112.4
Peanut Allergy	88.4	± 212.8
Egg Allergy	81.3	± 81.1

IgE post OIT

Group	Value	95% CI
Milk Allergy	4.1	± 5.4
Peanut Allergy	26.4	± 27.2
Egg Allergy	27.6	± 3.3

Adverse events — posted to ClinicalTrials.gov

Time frame: OIT after two years post start. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Milk Allergy

Serious: 4/12 (33%)

Deaths: 0/12

Peanut Allergy

Serious: 2/14 (14%)

Deaths: 0/14

Egg Allergy

Serious: 0/4 (0%)

Deaths: 0/4

Serious adverse events (1 terms)

Reaction	System	Milk Allergy	Peanut Allergy	Egg Allergy
Allergic reaction	Skin and subcutaneous tissue disorders	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Milk Allergy	Peanut Allergy	Egg Allergy
Local itching	Skin and subcutaneous tissue disorders	—	—	—

Most-reported serious reactions: Allergic reaction.

Data from ClinicalTrials.gov NCT03361072 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.