An interventional study of Dietary supplement in Food Allergy, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-02-11.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
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?
Up to 100 subjects are studied. All subjects are adults having no other severe chronic diseases. The subjects belong to four different groups:
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.
33 studies on the registry are indexed under Nut Hypersensitivity; 9 are open to participants now.
This study's enrollment of 23 is below the median of 47 across 20 interventional studies indexed under Nut Hypersensitivity.
Browse Nut Hypersensitivity studies →Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
Compared within Nut Hypersensitivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Food Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary supplement, milk in increasing dosages, delivered daily and orally.
Dietary Supplement: Dietary supplement
Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.
Dietary Supplement: Dietary supplement
Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.
Dietary Supplement: Dietary supplement
Milk, egg or nut oral immunotherapy
Also known as: Milk, Egg protein, Nut cream
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
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
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
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
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
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
| Milestone | Milk Allergy | Nut Allergy | Egg Allergy |
|---|---|---|---|
| Started | 10 | 9 | 4 |
| Completed | 6 | 4 | 3 |
| Not completed | 4 | 5 | 1 |
| Withdrew: Adverse event | 1 | 3 | 1 |
| Withdrew: Pregnancy | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 3 | 1 | 0 |
Number of the patients that achieve higher tolerance of allergen with immunotherapy in one year than the measured baseline allergen challenge shows.
| participants | Milk Allergy | Nut Allergy | Egg Allergy |
|---|---|---|---|
| Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy | 6 | 4 | 3 |
Does hyposensitisation change lung function (do spirometry tests show difference from the baseline values (= before immunotherapy) after the immunotherapy) ?
| percentage of predicted value | Milk Allergy | Nut Allergy | Egg Allergy |
|---|---|---|---|
| FEV1 (%) before OIT | 91.4 ± 7.4 | 96.1 ± 13.8 | 86.1 ± 8.9 |
| FEV1 (%) OIT | 92.1 ± 6.0 | 96.3 ± 7.4 | 84.0 ± 12.1 |
Does bronchial hyperreactivity (measured with methacholine bronchial challenge test) show change from the baseline level after the immunotherapy?
| Dose of methcholine, ug | Milk Allergy | Nut Allergy | Egg Allergy |
|---|---|---|---|
| Before OIT | 531.3 ± 696.1 | 1303.9 ± 1589.0 | 691.2 ± 507.4 |
| After OIT | 615.5 ± 0.0 | 2059.0 ± 0.0 | 973.4 ± 1029.1 |
Does the oral immunotherapy change exhaled nitric oxide levels (measured before and after immunotherapy)
| ppb | Milk Allergy | Nut Allergy | Egg Allergy |
|---|---|---|---|
| Before OIT | 45.3 ± 36.7 | 25.7 ± 19.2 | 66.6 ± 51.3 |
| After OIT | 22.5 ± 18.9 | 25.7 ± 18.1 | 66.2 ± 60.2 |
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?
| Participants | Milk Allergy | Nut Allergy | Egg Allergy |
|---|---|---|---|
| Mild side effects | 1 | 2 | 1 |
| Moderate side effects | 1 | 0 | 0 |
| Severe side effects | 0 | 1 | 0 |
| Quitting because of side effects | 1 | 2 | 1 |
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).
| VAS score (mm) | Milk Allergy | Nut Allergy | Egg Allergy |
|---|---|---|---|
| Before OIT | 83.9 ± 15.1 | 63.5 ± 23.3 | 61.0 ± 13.0 |
| After OIT | 73.0 ± 5.0 | — | — |
Collected over 4 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Milk Allergy | 0/10 (0%) | 2/10 (20%) | 8/10 (80%) |
| Nut Allergy | 0/9 (0%) | 1/9 (11.1%) | 6/9 (66.7%) |
| Egg Allergy | 0/4 (0%) | 0/4 (0%) | 3/4 (75%) |
| Event | Milk Allergy | Nut Allergy | Egg Allergy |
|---|---|---|---|
| Systemic allergic reactionImmune system disorders | 2/10 | 1/9 | 0/4 |
| Event | Milk Allergy | Nut Allergy | Egg Allergy |
|---|---|---|---|
| Mouth and throat itchingGastrointestinal disorders | 8/10 | 6/9 | 3/4 |
| Age, Categorical(Participants) | Milk Allergy | Nut Allergy | Egg Allergy | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 9 | 4 | 23 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Milk Allergy | Nut Allergy | Egg Allergy | Total |
|---|---|---|---|---|
| Female | 9 | 6 | 4 | 19 |
| Male | 1 | 3 | 0 | 4 |
| Race and Ethnicity Not Collected(Participants) | Milk Allergy | Nut Allergy | Egg Allergy | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | Milk Allergy | Nut Allergy | Egg Allergy | Total |
|---|---|---|---|---|
| Finland | 10 | 9 | 4 | 23 |
| Allergen specific IgE(kU/l) | Milk Allergy | Nut Allergy | Egg Allergy | Total |
|---|---|---|---|---|
| Mean | 57.8 ± 60.4 | 48.8 ± 104.1 | 22.4 ± 15.5 | 47.7 ± 75.6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Jan 2013 to primary completion in Nov 2017, 58 months.
Results were first posted in Aug 2019, 1 year 9 months after primary completion.
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Studies of the drug tested here: cow's milk
Helsinki University Central Hospital →