Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana).
Status:
Active, not recruiting
Trial end date:
2023-03-03
Target enrollment:
Participant gender:
Summary
Anaphylaxis elicited by accidental intake of the offending food constitutes a major health
risk to the food allergic patient. Current advice for the food allergic patient is to avoid
the offending food allergen and to carry an epinephrine autoinjector. However, novel
treatments altering the clinical reactivity to the offending food thereby diminishing the
risk of anaphylaxis are much needed. A correlation between the level of specific IgE in serum
towards the offending food and the clinical sensitivity of the patient has been suggested.
The clinical threshold for a food allergic reaction to occur is therefore hypothesized to
increase by reducing the level of specific IgE to the relevant food allergen.
Therapy with Omalizumab has proven efficacious in lowering the level of IgE in serum but a
high pre-treatment level of total IgE in serum potentially hampers the efficacy in a number
of patients, as seen especially in patients with concomitant atopic dermatitis. The aim of
this study is to investigate if the combination of initial IgE specific immunoadsorption
combined with subsequent treatment with Omalizumab will increase the clinical threshold to
the culprit food and thus prevent medical emergencies (anaphylaxis) in patients with severe
food allergy.