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).
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
Severe asthma
FEV1 < 80% (below the 5th percentile),
FEV1/FVC ratio < 75% (below the 5th percentile),
Hospitalization due to asthma exacerbation within the past 12 months
Parallel
OIT with cashew nut protein
Dietary supplementAfter 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.
Sustained unresponsiveness determined by the outcome of the OFC
Percentage of patients achieving sustained unresponsiveness after 1200 mg cashew nut protein oral immunotherapy, defined as tolerating 4 g of cashew nut powder in OFC after 4 weeks of cashew nut avoidance.
Changes in cashew nut protein tolerance during OFC
Comparison of the amount of cashew nut protein tolerated during each oral food challenge (OFC) by each patient. Every OFC will be performed according to PRACTALL guidelines.
Adverse event
Quantity and severity of adverse effect divided into 3 categories: mild, moderate and severe reactions.
Quality of life - FAQLQ (Food Allergy Quality of Life Questionnaire)
Assessment of the quality of life of patients and their families before each open oral cashew nut protein challenge trial (impact of allergy on family life) based on the Food Allergy Quality of Life Questionnaire (FAQLQ). Based on the FAQLQ score, quality of life will be assessed on a scale ranging from minimal to severe impairment due to food allergy.
Basophil activation test (BAT)
Assessment of CD63+ basophil marker expression prior to desensitisation and before any OFC.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
