Food Allergy
Conditions
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
Milk, egg or nut oral immunotherapy
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy | One year | Number of the patients that achieve higher tolerance of allergen with immunotherapy in one year than the measured baseline allergen challenge shows. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Therapy on Lung Function. | One year | Does 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 year | Does 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 year | Does the oral immunotherapy change exhaled nitric oxide levels (measured before and after immunotherapy) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect of Treatment on Quality of Life | one year | 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). |
| Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults. | One year | 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? |
Countries
Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 1 |
| Overall Study | Pregnancy | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 0 |
Baseline characteristics
| Characteristic | Milk Allergy | Nut Allergy | Egg Allergy | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 9 Participants | 4 Participants | 23 Participants |
| Allergen specific IgE | 57.8 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 Collected | — | — | — | 0 Participants |
| Region of Enrollment Finland | 10 participants | 9 participants | 4 participants | 23 participants |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 4 Participants | 19 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 | 0 / 4 |
| other Total, other adverse events | 8 / 10 | 6 / 9 | 3 / 4 |
| serious Total, serious adverse events | 2 / 10 | 1 / 9 | 0 / 4 |
Outcome results
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Milk Allergy | Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy | 6 participants |
| Nut Allergy | Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy | 4 participants |
| Egg Allergy | Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy | 3 participants |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Milk Allergy | Does Oral Immunotherapy Change Bronchial Hyperreactivity? | Before OIT | 531.3 Dose of methcholine, ug | Standard Deviation 696.1 |
| Milk Allergy | Does Oral Immunotherapy Change Bronchial Hyperreactivity? | After OIT | 615.5 Dose of methcholine, ug | Standard Deviation 0 |
| Nut Allergy | Does Oral Immunotherapy Change Bronchial Hyperreactivity? | Before OIT | 1303.9 Dose of methcholine, ug | Standard Deviation 1589 |
| Nut Allergy | Does Oral Immunotherapy Change Bronchial Hyperreactivity? | After OIT | 2059.0 Dose of methcholine, ug | Standard Deviation 0 |
| Egg Allergy | Does Oral Immunotherapy Change Bronchial Hyperreactivity? | Before OIT | 691.2 Dose of methcholine, ug | Standard Deviation 507.4 |
| Egg Allergy | Does Oral Immunotherapy Change Bronchial Hyperreactivity? | After OIT | 973.4 Dose of methcholine, ug | Standard Deviation 1029.1 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Milk Allergy | Does the Oral Immunotherapy Have en Effect on Airway Inflammation? | Before OIT | 45.3 ppb | Standard Deviation 36.7 |
| Milk Allergy | Does the Oral Immunotherapy Have en Effect on Airway Inflammation? | After OIT | 22.5 ppb | Standard Deviation 18.9 |
| Nut Allergy | Does the Oral Immunotherapy Have en Effect on Airway Inflammation? | Before OIT | 25.7 ppb | Standard Deviation 19.2 |
| Nut Allergy | Does the Oral Immunotherapy Have en Effect on Airway Inflammation? | After OIT | 25.7 ppb | Standard Deviation 18.1 |
| Egg Allergy | Does the Oral Immunotherapy Have en Effect on Airway Inflammation? | Before OIT | 66.6 ppb | Standard Deviation 51.3 |
| Egg Allergy | Does the Oral Immunotherapy Have en Effect on Airway Inflammation? | After OIT | 66.2 ppb | Standard Deviation 60.2 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Milk Allergy | Effect of Therapy on Lung Function. | FEV1 (%) before OIT | 91.4 percentage of predicted value | Standard Deviation 7.4 |
| Milk Allergy | Effect of Therapy on Lung Function. | FEV1 (%) OIT | 92.1 percentage of predicted value | Standard Deviation 6 |
| Nut Allergy | Effect of Therapy on Lung Function. | FEV1 (%) before OIT | 96.1 percentage of predicted value | Standard Deviation 13.8 |
| Nut Allergy | Effect of Therapy on Lung Function. | FEV1 (%) OIT | 96.3 percentage of predicted value | Standard Deviation 7.4 |
| Egg Allergy | Effect of Therapy on Lung Function. | FEV1 (%) before OIT | 86.1 percentage of predicted value | Standard Deviation 8.9 |
| Egg Allergy | Effect of Therapy on Lung Function. | FEV1 (%) OIT | 84.0 percentage of predicted value | Standard Deviation 12.1 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Milk Allergy | Effect of Treatment on Quality of Life | Before OIT | 83.9 VAS score (mm) | Standard Deviation 15.1 |
| Milk Allergy | Effect of Treatment on Quality of Life | After OIT | 73.0 VAS score (mm) | Standard Deviation 5 |
| Nut Allergy | Effect of Treatment on Quality of Life | Before OIT | 63.5 VAS score (mm) | Standard Deviation 23.3 |
| Egg Allergy | Effect of Treatment on Quality of Life | Before OIT | 61.0 VAS score (mm) | Standard Deviation 13 |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Milk Allergy | Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults. | Mild side effects | 1 Participants |
| Milk Allergy | Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults. | Moderate side effects | 1 Participants |
| Milk Allergy | Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults. | Severe side effects | 0 Participants |
| Milk Allergy | Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults. | Quitting because of side effects | 1 Participants |
| Nut Allergy | Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults. | Quitting because of side effects | 2 Participants |
| Nut Allergy | Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults. | Mild side effects | 2 Participants |
| Nut Allergy | Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults. | Severe side effects | 1 Participants |
| Nut Allergy | Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults. | Moderate side effects | 0 Participants |
| Egg Allergy | Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults. | Quitting because of side effects | 1 Participants |
| Egg Allergy | Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults. | Moderate side effects | 0 Participants |
| Egg Allergy | Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults. | Severe side effects | 0 Participants |
| Egg Allergy | Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults. | Mild side effects | 1 Participants |