N/A
N=23
The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk, and Nut Allergy in Adults
Food Allergy
Bottom Line
View on ClinicalTrials.gov: NCT01822353 ↗Enrolled (actual)
23
Serious AEs
13.0%
Results posted
Aug 2019
Primary outcome: Primary: Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy — 6; 4; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dietary supplement (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Helsinki University Central Hospital
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy |
6; 4; 3 | — |
| SECONDARY Effect of Therapy on Lung Function. |
91.4; 96.1; 86.1; 92.1; 96.3; 84.0 | — |
| SECONDARY Does Oral Immunotherapy Change Bronchial Hyperreactivity? |
531.3; 1303.9; 691.2; 615.5; 2059.0; 973.4 | — |
| SECONDARY Does the Oral Immunotherapy Have en Effect on Airway Inflammation? |
45.3; 25.7; 66.6; 22.5; 25.7; 66.2 | — |
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?
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01822353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.