Food Allergy
Conditions
Keywords
oral immunotherapy, milk, peanut, egg, adult
Brief 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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTOral immunotherapy
Milk, peanut or egg oral immunotherapy
Sponsors
Helsinki University Central Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective open label study on oral immunotherapy with either milk, or peanut or egg white food products.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Desensitisation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Worries Associated With Food Allergy | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events | 1 year, through study completion | Follow-up of safety of OIT, Number of participants with treatment-related adverse events |
| Decrease in Allergen Specific IgE Values | 1 year, through study completion | Allergen specific IgE values before OIT and after OIT (kU/l) |
Countries
Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Milk Allergy Milk oral immunotherapy intervention for milk allergy
Oral immunotherapy: Milk, peanut or egg oral immunotherapy | 12 |
| Peanut Allergy Peanut oral immunotherapy intervention for peanut allergy
Oral immunotherapy: Milk, peanut or egg oral immunotherapy | 14 |
| Egg Allergy Egg oral immunotherapy intervention for egg allergy
Oral immunotherapy: Milk, peanut or egg oral immunotherapy | 4 |
| Total | 30 |
Baseline characteristics
| Characteristic | Peanut Allergy | Egg Allergy | Total | Milk Allergy |
|---|---|---|---|---|
| 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 | 14 Participants | 4 Participants | 30 Participants | 12 Participants |
| Age, Continuous | 29.6 years STANDARD_DEVIATION 11 | 25.3 years STANDARD_DEVIATION 20.5 | 31.1 years STANDARD_DEVIATION 10.3 | 34.8 years STANDARD_DEVIATION 12.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 4 Participants | 30 Participants | 12 Participants |
| Region of Enrollment Finland | 14 participants | 4 participants | 30 participants | 12 participants |
| Sex: Female, Male Female | 9 Participants | 4 Participants | 24 Participants | 11 Participants |
| Sex: Female, Male Male | 5 Participants | 0 Participants | 6 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 14 | 0 / 4 |
| other Total, other adverse events | 8 / 12 | 12 / 14 | 4 / 4 |
| serious Total, serious adverse events | 4 / 12 | 2 / 14 | 0 / 4 |
Outcome results
Primary
Desensitisation
Increase in tolerated dose (that is no symptoms if accidental exposure) of food compared to the pre-OIT, number of participants
Time frame: 1 year, through study completion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Milk Allergy | Desensitisation | 7 Participants |
| Peanut Allergy | Desensitisation | 5 Participants |
| Egg Allergy | Desensitisation | 2 Participants |
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
Time frame: 1 year, through study completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Milk Allergy | Worries Associated With Food Allergy | Before OIT (VAS) | 77.7 score on a scale | Standard Deviation 19.2 |
| Milk Allergy | Worries Associated With Food Allergy | After OIT, at one year (VAS) | 79.00 score on a scale | Standard Deviation 5.6 |
| Peanut Allergy | Worries Associated With Food Allergy | Before OIT (VAS) | 69.7 score on a scale | Standard Deviation 12.4 |
| Peanut Allergy | Worries Associated With Food Allergy | After OIT, at one year (VAS) | 39.5 score on a scale | Standard Deviation 19.1 |
| Egg Allergy | Worries Associated With Food Allergy | Before OIT (VAS) | 61.0 score on a scale | Standard Deviation 13 |
| Egg Allergy | Worries Associated With Food Allergy | After OIT, at one year (VAS) | 25.0 score on a scale | Standard Deviation 0 |
Other Pre-specified
Decrease in Allergen Specific IgE Values
Allergen specific IgE values before OIT and after OIT (kU/l)
Time frame: 1 year, through study completion
Population: S-IgE milk for milk allergy, S-IgE peanut for peanut allergy, S-IgE egg white for egg allergy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Milk Allergy | Decrease in Allergen Specific IgE Values | IgE pre OIT | 100.7 kU/l | Standard Deviation 112.4 |
| Milk Allergy | Decrease in Allergen Specific IgE Values | IgE post OIT | 4.1 kU/l | Standard Deviation 5.4 |
| Peanut Allergy | Decrease in Allergen Specific IgE Values | IgE pre OIT | 88.4 kU/l | Standard Deviation 212.8 |
| Peanut Allergy | Decrease in Allergen Specific IgE Values | IgE post OIT | 26.4 kU/l | Standard Deviation 27.2 |
| Egg Allergy | Decrease in Allergen Specific IgE Values | IgE pre OIT | 81.3 kU/l | Standard Deviation 81.1 |
| Egg Allergy | Decrease in Allergen Specific IgE Values | IgE post OIT | 27.6 kU/l | Standard Deviation 3.3 |
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
Time frame: 1 year, through study completion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Milk Allergy | Number of Participants With Treatment-related Adverse Events | 12 Participants |
| Peanut Allergy | Number of Participants With Treatment-related Adverse Events | 14 Participants |
| Egg Allergy | Number of Participants With Treatment-related Adverse Events | 4 Participants |