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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milk allergy | Experimental | Milk oral immunotherapy intervention for milk allergy |
|
| Peanut allergy | Experimental | Peanut oral immunotherapy intervention for peanut allergy |
|
| Egg allergy | Experimental | Egg oral immunotherapy intervention for egg allergy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral immunotherapy | Dietary Supplement | Milk, peanut or egg oral immunotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Desensitisation | Increase in tolerated dose (that is no symptoms if accidental exposure) of food compared to the pre-OIT, number of participants | 1 year, through study completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events | Follow-up of safety of OIT, Number of participants with treatment-related adverse events | 1 year, through study completion |
| Decrease in Allergen Specific IgE Values |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula Kauppi, MD, PhD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital | Helsinki | 00029 | Finland |
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| ID | Title | Description |
|---|---|---|
| FG000 | Milk Allergy | Milk oral immunotherapy intervention for milk allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy |
| FG001 | Peanut Allergy | Peanut oral immunotherapy intervention for peanut allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy |
| FG002 | Egg Allergy | Egg oral immunotherapy intervention for egg allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Milk Allergy | Milk oral immunotherapy intervention for milk allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy |
| BG001 | Peanut Allergy | Peanut oral immunotherapy intervention for peanut allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Desensitisation | Increase in tolerated dose (that is no symptoms if accidental exposure) of food compared to the pre-OIT, number of participants | Posted | Count of Participants | Participants | 1 year, through study completion |
|
OIT after two years post start
OIT after two years post start
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Milk Allergy | Milk oral immunotherapy intervention for milk allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment | EpiPen usage or emergency visit because of OIT and allergy reaction |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Paula Kauppi | Helsinki University Hospital | +358504286802 | paula.kauppi@hus.fi |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2017 | Oct 12, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Prospective open label study on oral immunotherapy with either milk, or peanut or egg white food products.
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Allergen specific IgE values before OIT and after OIT (kU/l)
| 1 year, through study completion |
| BG002 | Egg Allergy | Egg oral immunotherapy intervention for egg allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Egg oral immunotherapy intervention for egg allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy |
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | 1 year, through study completion |
|
|
|
| Other Pre-specified | Number of Participants With Treatment-related Adverse Events | Follow-up of safety of OIT, Number of participants with treatment-related adverse events | Posted | Count of Participants | Participants | 1 year, through study completion |
|
|
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| Other Pre-specified | Decrease in Allergen Specific IgE Values | Allergen specific IgE values before OIT and after OIT (kU/l) | S-IgE milk for milk allergy, S-IgE peanut for peanut allergy, S-IgE egg white for egg allergy | Posted | Mean | Standard Deviation | kU/l | 1 year, through study completion |
|
|
|
| 0 |
| 12 |
| 4 |
| 12 |
| 8 |
| 12 |
| EG001 | Peanut Allergy | Peanut oral immunotherapy intervention for peanut allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy | 0 | 14 | 2 | 14 | 12 | 14 |
| EG002 | Egg Allergy | Egg oral immunotherapy intervention for egg allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy | 0 | 4 | 0 | 4 | 4 | 4 |
|
Investigators will postpone single-site publications until after publication.
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