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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01822353
Enrollment
23
Registered
2013-04-02
Start date
2013-01-31
Completion date
2017-11-30
Last updated
2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Allergy

Keywords

food allergy, milk allergy, egg allergy, nut allergy

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?

Detailed description

Up to 100 subjects are studied. All subjects are adults having no other severe chronic diseases. The subjects belong to four different groups: 1. 30 18-50 year olds who start per oral immunotherapy treatment in severe egg allergy. 2. 30 18-50 year olds who start per oral immunotherapy treatment in severe milk allergy. 3. 30 18-50 year olds who start per oral immunotherapy treatment in severe nut allergy. 4. 10 milk allergic 18-50 year olds that have been treated as pilot patients with milk hyposensitisation treatment. The diagnosis of milk or egg allergy is verified with positive history, skin prick test, egg, milk and nut allergen specific IgE antibodies. In addition, food allergy is verified with an allergen specific challenge test. Atopic subjects may have simultaneously other allergies. Intermittent mild asthma, and mild and moderate persistent asthma are tolerated and treatment with inhaled steroids and other asthma medication is allowed. Atopic subjects may have additional skin symptoms. Quality of life, anxiety and patient history data is collected by questionnaires. All patients undergo a spirometry with a bronchodilatation test, fractional exhaled nitric oxide and a methacholine challenge before and a year after oral immunotherapy. Those with test results diagnostic for asthma are treated with asthma medication before hyposensitisation treatment is started. Exclusion criteria: adults with instable cerebrovascular or heart disease, active autoimmune disease or cancer, or use of betablocker agents. In addition, poorly controlled asthma or FEV1 \< 70% are not tolerated. In oral immunotherapy, increasing doses are given first observed, and then daily at home. If the subject does not tolerate a given dose and symptoms are mild, then that dose or the previously tolerated one is repeated, and the protocol proceeds as outlined. If the subject experiences significant symptoms, then the protocol is stopped, and the highest tolerated dose is used as the starting daily one.

Interventions

DIETARY_SUPPLEMENTDietary supplement

Milk, egg or nut oral immunotherapy

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* severe IgE-mediated milk allergy or * severe IgE-mediated egg allergy or * severe IgE-mediated nut allergy or * 18-50 years

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Number of the Patients That Achieve Higher Tolerance of Allergen With ImmunotherapyOne yearNumber of the patients that achieve higher tolerance of allergen with immunotherapy in one year than the measured baseline allergen challenge shows.

Secondary

MeasureTime frameDescription
Effect of Therapy on Lung Function.One yearDoes hyposensitisation change lung function (do spirometry tests show difference from the baseline values (= before immunotherapy) after the immunotherapy) ?
Does Oral Immunotherapy Change Bronchial Hyperreactivity?One yearDoes bronchial hyperreactivity (measured with methacholine bronchial challenge test) show change from the baseline level after the immunotherapy?
Does the Oral Immunotherapy Have en Effect on Airway Inflammation?One yearDoes the oral immunotherapy change exhaled nitric oxide levels (measured before and after immunotherapy)

Other

MeasureTime frameDescription
Effect of Treatment on Quality of Lifeone yearQuality of life is assessed by a questionnaire before and after immunotherapy (VAS scale on worries on allergy 0-100, 0 no worries, 100 maximal worries).
Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.One yearHow many of the patients have side effects (categorized as mild, moderate or severe)of the hyposensitisation and how many of the patients discontinue the therapy because of side effects?

Countries

Finland

Participant flow

Participants by arm

ArmCount
Milk Allergy
Dietary supplement, milk in increasing dosages, delivered daily and orally. Dietary supplement: Milk, egg or nut oral immunotherapy
10
Nut Allergy
Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally. Dietary supplement: Milk, egg or nut oral immunotherapy
9
Egg Allergy
Dietary supplement, egg protein given in increasing dosages, delivered daily and orally. Dietary supplement: Milk, egg or nut oral immunotherapy
4
Total23

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event131
Overall StudyPregnancy010
Overall StudyWithdrawal by Subject310

Baseline characteristics

CharacteristicMilk AllergyNut AllergyEgg AllergyTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants9 Participants4 Participants23 Participants
Allergen specific IgE57.8 kU/l
STANDARD_DEVIATION 60.4
48.8 kU/l
STANDARD_DEVIATION 104.1
22.4 kU/l
STANDARD_DEVIATION 15.5
47.7 kU/l
STANDARD_DEVIATION 75.6
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Finland
10 participants9 participants4 participants23 participants
Sex: Female, Male
Female
9 Participants6 Participants4 Participants19 Participants
Sex: Female, Male
Male
1 Participants3 Participants0 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 90 / 4
other
Total, other adverse events
8 / 106 / 93 / 4
serious
Total, serious adverse events
2 / 101 / 90 / 4

Outcome results

Primary

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.

Time frame: One year

ArmMeasureValue (NUMBER)
Milk AllergyNumber of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy6 participants
Nut AllergyNumber of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy4 participants
Egg AllergyNumber of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy3 participants
Secondary

Does Oral Immunotherapy Change Bronchial Hyperreactivity?

Does bronchial hyperreactivity (measured with methacholine bronchial challenge test) show change from the baseline level after the immunotherapy?

Time frame: One year

Population: Drop out in the number of study individuals in the methacholine measurements at one year after OIT

ArmMeasureGroupValue (MEAN)Dispersion
Milk AllergyDoes Oral Immunotherapy Change Bronchial Hyperreactivity?Before OIT531.3 Dose of methcholine, ugStandard Deviation 696.1
Milk AllergyDoes Oral Immunotherapy Change Bronchial Hyperreactivity?After OIT615.5 Dose of methcholine, ugStandard Deviation 0
Nut AllergyDoes Oral Immunotherapy Change Bronchial Hyperreactivity?Before OIT1303.9 Dose of methcholine, ugStandard Deviation 1589
Nut AllergyDoes Oral Immunotherapy Change Bronchial Hyperreactivity?After OIT2059.0 Dose of methcholine, ugStandard Deviation 0
Egg AllergyDoes Oral Immunotherapy Change Bronchial Hyperreactivity?Before OIT691.2 Dose of methcholine, ugStandard Deviation 507.4
Egg AllergyDoes Oral Immunotherapy Change Bronchial Hyperreactivity?After OIT973.4 Dose of methcholine, ugStandard Deviation 1029.1
Secondary

Does the Oral Immunotherapy Have en Effect on Airway Inflammation?

Does the oral immunotherapy change exhaled nitric oxide levels (measured before and after immunotherapy)

Time frame: One year

ArmMeasureGroupValue (MEAN)Dispersion
Milk AllergyDoes the Oral Immunotherapy Have en Effect on Airway Inflammation?Before OIT45.3 ppbStandard Deviation 36.7
Milk AllergyDoes the Oral Immunotherapy Have en Effect on Airway Inflammation?After OIT22.5 ppbStandard Deviation 18.9
Nut AllergyDoes the Oral Immunotherapy Have en Effect on Airway Inflammation?Before OIT25.7 ppbStandard Deviation 19.2
Nut AllergyDoes the Oral Immunotherapy Have en Effect on Airway Inflammation?After OIT25.7 ppbStandard Deviation 18.1
Egg AllergyDoes the Oral Immunotherapy Have en Effect on Airway Inflammation?Before OIT66.6 ppbStandard Deviation 51.3
Egg AllergyDoes the Oral Immunotherapy Have en Effect on Airway Inflammation?After OIT66.2 ppbStandard Deviation 60.2
Secondary

Effect of Therapy on Lung Function.

Does hyposensitisation change lung function (do spirometry tests show difference from the baseline values (= before immunotherapy) after the immunotherapy) ?

Time frame: One year

ArmMeasureGroupValue (MEAN)Dispersion
Milk AllergyEffect of Therapy on Lung Function.FEV1 (%) before OIT91.4 percentage of predicted valueStandard Deviation 7.4
Milk AllergyEffect of Therapy on Lung Function.FEV1 (%) OIT92.1 percentage of predicted valueStandard Deviation 6
Nut AllergyEffect of Therapy on Lung Function.FEV1 (%) before OIT96.1 percentage of predicted valueStandard Deviation 13.8
Nut AllergyEffect of Therapy on Lung Function.FEV1 (%) OIT96.3 percentage of predicted valueStandard Deviation 7.4
Egg AllergyEffect of Therapy on Lung Function.FEV1 (%) before OIT86.1 percentage of predicted valueStandard Deviation 8.9
Egg AllergyEffect of Therapy on Lung Function.FEV1 (%) OIT84.0 percentage of predicted valueStandard Deviation 12.1
Other Pre-specified

Effect of Treatment on Quality of Life

Quality of life is assessed by a questionnaire before and after immunotherapy (VAS scale on worries on allergy 0-100, 0 no worries, 100 maximal worries).

Time frame: one year

Population: Drop out in answers for quality of life at one year after OIT

ArmMeasureGroupValue (MEAN)Dispersion
Milk AllergyEffect of Treatment on Quality of LifeBefore OIT83.9 VAS score (mm)Standard Deviation 15.1
Milk AllergyEffect of Treatment on Quality of LifeAfter OIT73.0 VAS score (mm)Standard Deviation 5
Nut AllergyEffect of Treatment on Quality of LifeBefore OIT63.5 VAS score (mm)Standard Deviation 23.3
Egg AllergyEffect of Treatment on Quality of LifeBefore OIT61.0 VAS score (mm)Standard Deviation 13
Other Pre-specified

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

How many of the patients have side effects (categorized as mild, moderate or severe)of the hyposensitisation and how many of the patients discontinue the therapy because of side effects?

Time frame: One year

ArmMeasureGroupValue (NUMBER)
Milk AllergySafety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.Mild side effects1 Participants
Milk AllergySafety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.Moderate side effects1 Participants
Milk AllergySafety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.Severe side effects0 Participants
Milk AllergySafety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.Quitting because of side effects1 Participants
Nut AllergySafety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.Quitting because of side effects2 Participants
Nut AllergySafety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.Mild side effects2 Participants
Nut AllergySafety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.Severe side effects1 Participants
Nut AllergySafety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.Moderate side effects0 Participants
Egg AllergySafety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.Quitting because of side effects1 Participants
Egg AllergySafety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.Moderate side effects0 Participants
Egg AllergySafety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.Severe side effects0 Participants
Egg AllergySafety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.Mild side effects1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026