An observational study in Tree Nut Allergy, sponsored by National and Kapodistrian University of Athens. Active, not recruiting at 1 site in Greece. Open to participants aged 5 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by National and Kapodistrian University of Athens · Observational
This study aims to compare the safety and the compliance to different procedures (A: at home or B: at the hospital) for introducing tree nuts into the diet of patients with Immunoglobulin E (IgE)-mediated allergy to the aforementioned nuts. In parallel, the effectiveness of tree nuts' introduction in respect to tolerance induction compared to the standard care (strict avoidance of tree nuts) will be evaluated.
This is a multi-centered observational study comparing the safety and compliance of different procedures for introducing tree nuts into the diet of patients with IgE-mediated allergy to nuts. The effectiveness of tree nuts' introduction in respect to tolerance induction compared to the standard care (strict avoidance of tree nuts) will also be evaluated.
The study will be contacted in the Department of Allergy and Clinical Immunology, 2nd University Pediatric Clinic of "Panagiotis \& Aglaia Kyriakou" Children's Hospital, Athens, Greece, in collaboration with the Allergy Unit "Dimitrios Kalogeromitros, 2nd University Clinic of Dermatology and Venereology, "Attikon" University Hospital, University of Athens, Greece and the Allergology Department of "Laiko" General Hospital, Athens, Greece.
The study will include participants with persistent IgE mediated allergy to tree nuts (including at least walnut or pistachio) who are willing to follow one of the two induction procedures (A: at home, B: at the hospital) and voluntarily provide written consent in the procedures and the goals of the study. Participants will adhere to one of the two induction procedures according to their preferences. Groups will be matched in respect to the number of participants.
Participants who have already followed one of the two procedures can participate following written informed consent.
The control group consists of participants who do not wish to introduce tree nuts into their diet but will consent to provide their medical data and the results of their allergology work-up for research purposes. The target ratio between active and control groups will be 3:1.
Introduction of Tree Nuts consists of:
Baseline Assessment (Screening period):
In all participants, active and control, IgE-mediated allergy is evaluated by Skin Prick Tests (SPTs), serum specific IgE (sIgE) to tree nuts, serum sIgE to tree nuts' components and Basophile Activation Test (BAT) to the implicated tree nut and is confirmed by oral food challenges (OFC) with the nut. Additionally, total IgE and tryptase levels are assessed.
Tree Nuts' Introduction Phase:
Commercially available drinks of the respective tree nut, in suitable dilutions, are used for the introduction.
First day of introduction: Participants in both active groups (procedures A and B) receive the first dose of the drink in the hospital under specialized medical observation.
Escalation period: Drinks in suitable dilutions are given daily to participants. Dose escalation is performed at weekly intervals at home (procedure A) or every 2 months at the hospital (procedure B) until reaching maintenance dose or patient's maximum tolerated dose. The escalation period is estimated at 64 weeks (16 months). The up-dosing scheme and maintenance dose and duration will be adjusted in case of adverse allergic reactions.
Maintenance Phase: The maintenance starts when participants reach the maintenance dose or their maximum tolerated dose, and lasts for at least 4 weeks.
Participants in the control group are instructed to strictly avoid offending tree nuts, as per standard care.
During Tree Nuts' Introduction Phase all participants, active and control, will be followed up periodically in two months intervals.
Final Assessment:
After completing at least 4 weeks at maintenance phase all participants will undergo an open oral food challenge with the offending nut(s) to assess tolerance. SPTs, total IgE, serum sIgE to tree nuts, serum sIgE to tree nuts' components and Basophile Activation Test (BAT) to each tree nut the participant is allergic will be re-evaluated.
33 studies on the registry are indexed under Nut Hypersensitivity; 9 are open to participants now.
This study's planned enrollment of 60 is below the median of 240 across 11 observational studies indexed under Nut Hypersensitivity.
Browse Nut Hypersensitivity studies →National and Kapodistrian University of Athens is the lead sponsor of 176 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children and adults seen in specialized Allergy Departments of three hospitals in Athens with allergy to at least one of the tree nuts studied, namely walnut, cashew and/or pistachio.
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.
Male or female participants aged 5 through 40 years, in a good general health condition according to the participant's medical history and the clinical examination and no chronic diseases, except:
Exclusion Criteria:
Systematically used :
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with allergy to tree nuts who follow the introduction procedure A (at home)
Other: Procedure A
Participants with allergy to tree nuts who follow the introduction procedure B (at the hospital)
Other: Procedure B
Participants with allergy to tree nuts who follow strict avoidance of the offending nuts.
Other: Control group
Up-dosing nut drink at home
Up-dosing nut drink at the hospital
Strict avoidance of tree nut consumption
Number and severity of allergic reactions in procedure A and procedure B.
Comparison of the frequency and severity of allergic reactions, and the frequency of adrenaline use in two remedies.
Time frame: 2 years.
Number of patients who adhere to each procedure (A or B).
Comparison of the proportion of participants who follow the procedure.
Time frame: 2 years.
Number of participants with tolerance induction after procedure A and B compared to strict avoidance.
The proportion of participants in each group who achieve to consume 300mg of tree nut protein at Final Assessment (cumulative dose of 433mg ), if baseline provocation dose was ≤100mg, or 1000mg (cumulative dose 1433mg), if baseline provocation dose was ≥300mg.
Time frame: 2 years.
Comparison of the mean change in the maximum tolerated dose in participants following procedure A compared to procedure B.
The change in the maximum tolerated dose of the tree nut between baseline and final assessment.
Time frame: 2 years.
Immunological alterations induced by the two procedures.
Alterations in SPTs, sIgEs and BAT outcomes between baseline and final assesment.
Time frame: 2 years.
Mean change from baseline in Food Allergy Quality of Life Questionnaire- Food Allergy Independent Measure (FAQLQ-FAIM)-Likert scale-questions , range from 1 'not troubled' to 7 'extremely troubled'.
The effect of two procedures in quality of life of patients as measured by FAQLQ-FAIM at baseline, 6 months and final assessment.The Food Allergy Quality of Life Questionnaires (FAQLQ) are disease-specific health-related quality of life (HRQL) questionnaires for patients with food allergy.The number of items of each FAQLQ ranges from 23 to 30 items, depending on age. Each question is answered on a 7-point scale (0 "no impairment" to 6 "maximal impairment" ).
Time frame: 2 years.
Mean change from baseline in specific Immunoglobulin G (IgG) and Immunoglobulin G4 (IgG4) serum levels.
The effect of each procedure or avoidance in the levels of serum IgG and IgG4.
Time frame: 2 years
Epigenetic and transcriptomic changes related to tolerance induction.
The effect of each procedure or avoidance in immune response at the level of epigenetics and transcriptomics.
Time frame: 2 years
Changes in the gut microbiome of participants.
The effect of each procedure or avoidance in the population,the composition and the variety of the gut microbiome.
Time frame: 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2019 (actual). Primary completion is estimated for May 2024, 58 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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