Clinical Research Directory

Understanding the Immune System's Role in Tree Nut and Peanut Allergies: Key Biomarkers for Diagnosis and Treatment Monitoring and Treatment Targets

Peanut and tree nuts belong to the main elicitors of pediatric food allergy and are the main cause of near fatal reactions in children requiring emergency management. Oral immunotherapy has emerged as an alternative treatment option for the management of food allergies, to enhance patients' safety and quality of life. Monitoring if the therapy is working relies on oral food challenges during the course of treatment. There is a clear need for reliable biomarkers that are reflective of the clinical progression during oral food challenges and during immunotherapy that would help with patient stratification and possibly for personalized treatment approaches in the future The aim of this study is to measure immune parameters in the blood of nut-allergic participants during oral food challenges and during the course of oral immunotherapy. The main questions the study aims to answer are: 1. Identify immune markers that correlate with clinical reactivity 2. Identify immune changes and markers that correlate with immunotherapy outcome Researchers will compare these immune parameters between nut-allergic participants on oral immunotherapy and with nut-allergic participants on avoidance diet. Additionally, we will also compare the immune parameters of these nut-allergic participants with those healthy adults.

Randomized Controlled Trial of Slow Multiallergen Oral Immunotherapy in Young Children

The aim is to study whether a multiallergen oral immunotherapy (OIT) strategy with slow up-dosing and low treatment dose against food allergy in young children (0.5-3 years) is safe and effective, a method to cure food allergy and to prevent the development of new food allergies. Clinical randomized controlled (1:1) blinded interventional trial (RCT) with 2 intervention arms (group A and B). Among 80 children reacting at the multiallergen food challenge, 40 children will be randomized to receive OIT (oral immunotherapy) with multiallergen powder with a final dose of approximately 200 mg protein of each included food (egg, milk, soy, wheat, walnut, peanut, hazelnut, cashew, almond, lentils)(group A) or to receive placebo powder (gluten-free oatmeal) (group B). A sub-analysis will be performed of the children not reacting to the baseline challenge, who will be randomized to eat a low dose of the multiallergen powder (group C) or placebo powder (gluten-free oatmeal) (group D) and no specific advice.

The NACHO Trial (Nut Allergy Children OIT)

Most food allergies that begin in early childhood are mild and resolve by school age, but nut allergies persist in about 80-90% of individuals into adulthood. The consumption of nuts, particularly cashew nuts, has increased dramatically in Finland in the 21st century, leading to a rise in severe allergic reactions to cashew nuts among young children. Of the food anaphylaxis cases reported in the Finnish Anaphylaxis Registry between 2015-2020, 49% were caused by nuts, with cashew nuts being the most common trigger. The standard treatment for nut allergies is strict avoidance of nuts and symptom management with emergency medications. Oral immunotherapy (OIT) is a food allergy treatment that increases tolerance, and it has primarily been studied in school-aged children, with desensitization achieved in about 80% of cases. Permanent tolerance, depending on the allergen, develops in 30-50% of cases within five years. International guidelines recommend peanut OIT for children over the age of 4 who have severe peanut allergies. The likelihood of achieving tolerance, especially permanent tolerance, appears to improve the earlier the treatment is started. To date, only one study (NUIT CRACKER) has been published on cashew nut desensitization in children over 4 years old, involving 50 children, where 88% achieved desensitization to both cashew nuts and pistachios. The aim of this study is to develop a cashew nut desensitization protocol and investigate its effectiveness in achieving tolerance and permanent desensitization in children aged 1-17 years, compared to cashew nut avoidance. The study will assess the safety of cashew nut desensitization and its impact on the quality of life of patients and their families.