Sustained Unresponsiveness (SU) to Cashew Nut Protein Following Oral Allergen-Specific Immunotherapy

Study Purpose

This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy of Cashew Nut Protein Immunotherapy: A Protocol of a Single-Center Randomized Controlled Trial in the Pediatric Population", NCT06328504. At the end of the original RCT all participants will undergo an open Oral Food Challenge (OFC) to assess desensitization after 3 months on the maintenance dose of OIT. Patients who have completed the first part of the study will be invited to the current part of the project:

- First arm (initial experimental group) - patients will continue oral immunotherapy (OIT) with cashew nut protein (1200mg) for the next 8 months (+/- 3 weeks).

- Second arm (initial control group - one year on a cashew nut elimination diet) - patients will begin OIT following the protocol used in the first part of the study (RCT).

Upon completion of this initial phase, they will continue immunotherapy for an additional 8 months (+/- 3 weeks). After an additional 8 months (+/- 3 weeks) of OIT, all study participants will undergo a 4-week cessation of treatment, followed by an open Oral Food Challenge (OFC) to assess the development of sustained unresponsiveness (SU).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	4 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Cashew nut allergy confirmed prior to the initiation of immunotherapy.

- Completion of the first phase of the study, including achievement of the maintenance dose (1200 mg of cashew nut protein) during immunotherapy.

- Provision of informed consent for participation in the study.

- Adequate cooperation from the patient and/or their legal guardians.

Exclusion Criteria:

- Severe asthma.

- Poorly controlled mild-to-moderate asthma, defined as: - FEV1 < 80% (below the 5th percentile), - FEV1/FVC ratio < 75% (below the 5th percentile), - Hospitalization due to asthma exacerbation within the past 12 months.

- Oral, sublingual, or subcutaneous immunotherapy for other allergens during the first year/season of therapy.

- Eosinophilic gastrointestinal disorders.

- Severe, recurrent episodes of anaphylaxis within the last 6 months.

- Chronic illnesses requiring ongoing treatment, including: - Cardiac conditions.

- Epilepsy.

- Metabolic disorders.

- Diabetes mellitus.

- Use of the following medications: - Daily oral corticosteroid therapy >1 month within the past 12 months.

- At least two courses of oral corticosteroids (minimum duration of 7 days each) in the past 12 months.

- One course of oral corticosteroids (minimum 7 days) within the past 3 months.

- Biologic therapies.

- Treatment with β-blockers, ACE inhibitors, or calcium channel blockers.

- Pregnancy.

- Lack of informed consent for participation.

- Lack of cooperation from the patient

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07158619
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Medical University of Warsaw
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Poland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy in Children

Additional Details

Oral immunotherapy (OIT) is currently recognized as the most effective disease-modifying intervention for IgE-mediated food allergies. The therapeutic objectives of OIT encompass two distinct immunologic outcomes: desensitization and sustained unresponsiveness (SU). Desensitization refers to a reversible state of increased clinical tolerance to the allergen, dependent on continuous antigen exposure. In contrast, sustained unresponsiveness-considered the optimal endpoint-describes the maintenance of non-reactivity to the allergen following a defined period of OIT discontinuation. The present study constitutes a long-term follow-up of participants previously enrolled in the randomized controlled trial (RCT) "Efficacy of Cashew Nut Protein Immunotherapy: A Protocol of a Single-Center Randomized Controlled Trial in the Pediatric Population", NCT06328504. Participants who completed the initial treatment phase will be invited to participate in this extended evaluation. Study Procedures.Following an additional 8 months (±3 weeks) of continued cashew nut protein OIT, eligible participants will undergo a comprehensive in-hospital evaluation, including: Skin prick testing (SPT) with commercial extracts of peanut, walnut, hazelnut, pistachio, cashew, almond, and native tests with cashew flour, peanut butter, and fresh nuts listed above.Laboratory assessments (e.g., specific IgE, IgG4), and.A standardized open oral food challenge (OFC) to cashew nut protein to assess clinical desensitization. Participants who demonstrated confirmed desensitization (i.e., negative OFC) after 3 months of OIT during the initial trial phase will proceed to the next phase of the study protocol without repeating an OFC prior to OIT cessation. Only those with previously confirmed desensitization will be eligible for assessment of sustained unresponsiveness. Following a 4-week discontinuation period (i.e., OIT treatment break), these participants will undergo a second OFC to evaluate sustained unresponsiveness to cashew nut protein. Participants who did not achieve desensitization during the initial or extended phases-defined by a positive OFC-will resume cashew nut protein OIT per the established clinical desensitization protocol implemented at the investigational site, irrespective of their initial randomization group. Statistical Considerations.An interim analysis is planned once 70% of participants have completed the primary outcome assessment. This analysis will be conducted by an independent Data Monitoring Committee (DMC) to ensure participant safety and evaluate preliminary efficacy signals. Statistical inference during interim analysis will be controlled using appropriate alpha-spending functions to maintain the overall Type I error rate.

Arms & Interventions

Arms

Experimental: Maintenance dose of cashew nut protein (1200mg) for 8 months

Patients assigned to the experimental group in the first part of the study (RCT) will continue OIT with the maintenance dose of cashew nut protein (1200mg) for the next 8 months.

Experimental: Immunotherapy initiated after one year of cashew nut avoidance

Patients assigned to the control group in the first part of the study, after one year on a cashew nut elimination diet, will begin immunotherapy following the protocol used in the first part of the study (RCT). Upon completion of this initial phase, they will continue immunotherapy for an additional 8 months.

Interventions

Dietary Supplement: - OIT with cashew nut protein

After 8 months of continued oral immunotherapy (OIT) with cashew nuts, patients will undergo hospital-based assessments, including skin prick testing, laboratory evaluations, and an open Oral Food Challenge (OFC) to assess desensitization. Patients who had a negative OFC after 3 months in the initial phase-confirming desensitization-will skip the pre-break OFC and proceed directly to the next stage. Following a 4-week interruption in OIT, patients will return for a final hospital visit, during which a concluding OFC will be conducted to evaluate sustained unresponsiveness. Additional laboratory tests and skin prick testing will also be performed during this visit.

Contact a Trial Team

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International Sites

Medical University of Warsaw, Warsaw 756135, Masovian Voivodeship 858787, Poland

Status

Address

Medical University of Warsaw

Warsaw 756135, Masovian Voivodeship 858787, 02-091

Site Contact

Katarzyna Grzela, MD, PhD

[email protected]

+48 22 3179431

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