NCT07158619

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

Evaluation of the Acquisition of Sustained Unresponsiveness to Cashew Nut Protein Following Oral Allergen-Specific Immunotherapy - Long-Term Follow-Up of Patients From the RCT "Efficacy of Cashew Nut Protein Immunotherapy: A Protocol of a Single-Center Randomized Controlled Trial in the Pediatric Population" (NCT06328504)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Food Allergy in Children

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-12-01
• Completion: 2029-05-01
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

1 site across 1 country: Poland