Re-Introducing Nuts in Allergic Patients

NCT04151069 | Active Not Recruiting

• 1 other identifier: 1718037516
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tree Nut Allergy

Keywords

Tree Nut Allergy; Walnut Allergy; Pistachio Allergy; Cashew Allergy; Tree Nut Hypersensitivity; Tree Nut Anaphylaxis

Outcome Measures

Primary Outcomes (3)

• 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.

  2 years.

• Number of patients who adhere to each procedure (A or B).

  Comparison of the proportion of participants who follow the procedure.

  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.

  2 years.

Secondary Outcomes (3)

• Comparison of the mean change in the maximum tolerated dose in participants following procedure A compared to procedure B.

  2 years.

• Immunological alterations induced by the two procedures.

  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'.

  2 years.

Other Outcomes (3)

• Mean change from baseline in specific Immunoglobulin G (IgG) and Immunoglobulin G4 (IgG4) serum levels.

  2 years

• Epigenetic and transcriptomic changes related to tolerance induction.

  2 years

• Changes in the gut microbiome of participants.

  2 years

Study Arms (3)

At home group

Participants with allergy to tree nuts who follow the introduction procedure A (at home)

Other: Procedure A

At the hospital group

Participants with allergy to tree nuts who follow the introduction procedure B (at the hospital)

Other: Procedure B

Control group

Participants with allergy to tree nuts who follow strict avoidance of the offending nuts.

Other: Control group

Interventions

Procedure A OTHER

Up-dosing nut drink at home

At home group

Procedure B OTHER

Up-dosing nut drink at the hospital

At the hospital group

Control group OTHER

Strict avoidance of tree nut consumption

Control group

Eligibility Criteria

• Age: 5 Years - 40 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Written informed consent from adult participants or parent/guardian for children. Written assent from participants above the age of 12 years.
• 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:
• Allergic rhinitis
• Asthma controlled with therapy steps 1-3 according to Global Initiative for Asthma (GINA) 2017.
• Well-controlled atopic dermatitis.
• SPT to tree nut's extract and/or the natural tree nut (Prick-to-Prick) ≥ 3 mm (the largest diameter of the wheal) and serum IgE to tree nut of ≥ 0.35 kUA/L.
• sIgE \> 0.1 kUA/L to at least one seed storage protein of the offending tree nut, except for pistachio, where Ana o 3 will serve as a sensitization marker.
• Positive baseline OFC, at any dose but the final, conducted following PRACTALL (Practical Issues in Allergology, Joint United States/European Union Initiative) / iFAAM (Integrated Approaches to Food Allergen and Allergy Risk Management) guidelines.
• Forced Expiratory Volume at 1 second (FEV1) or Peak Expiratory Flow Rate (PEFR) ≥ 80% of predictive.
• The participant and/or the legal custodian should agree to comply with the study procedures.

You may not qualify if:

• History of systematic anaphylaxis GRADE 5 according to Sampson (loss of bowel control, respiratory arrest, severe bradycardia and/or hypotension or cardiac arrest, loss of consciousness) or/and during OFC.
• Recent (within 12 months) initiation of immunotherapy to any allergen.
• Past or present eosinophilic esophagitis (EoE).
• Chronic urticaria.
• Severe or uncontrolled atopic dermatitis.
• Uncontrolled asthma of any severity or asthma controlled with therapy steps 4-5 according to GINA 2017.
• Concurrent or within 6 months therapy with omalizumab or another monoclonal antibody.
• Systematically used corticosteroids:
• Daily for more than a month during the last year,
• Courses of corticosteroids during the last 3 months.
• \>2 Courses of corticosteroids lasting ≥1 week during the last year.
• Inability to discontinue antihistamines 4 days before skin prick testing or OFC.
• Severe immune disease, severe cardiovascular disease, malignancy, chronic infection, poor compliance, and severe psychiatric disorders.
• Any important clinical condition that can affect the safety of the participant or the results of the study, including but not limited to cardiovascular diseases, malignancies, diseases of the liver and/or the kidneys, hematologic diseases, physiologic, immunologic and endocrinologic diseases.
• Use of beta-blockers, angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARB).

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Hellenic Society of Allergology and Clinical Immunology: collaborator

Study Sites (1)

Department of Allergy and Clinical Immunology, 2nd University Pediatric Clinic of "Panagiotis & Aglaia Kyriakou" Children's Hospital, Athens, Greece

Athens, Attica, 11527, Greece

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum Whole Blood Stool

MeSH Terms

Conditions

Nut Hypersensitivity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 5, 2019
• Study Start: July 16, 2019
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

GR (1)