[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605138":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":46,"collaborators":24,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":24,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":24,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":69,"whyStopped":24,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Medical University of Warsaw","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Maintenance dose of cashew nut protein (1200mg) for 8 months","EXPERIMENTAL","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.",[13],"Dietary Supplement: OIT with cashew nut protein",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"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.",[15,9],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Katarzyna Grzela, MD, PhD","CONTACT","+48 22 3179431","katarzyna.grzela@wum.edu.pl",[32],{"facility":5,"status":24,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Warsaw","Masovian Voivodeship","02-091","Poland","PL",{"type":39,"coordinates":40},"Point",[41,42],21.01178,52.22977,{"lat":42,"lon":41},[45],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},{"type":47,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100605138","sustained-unresponsiveness-su-to-cashew-nut-protein-following-oral-allergen-specific-immunotherapy-100605138",false,"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)","Inclusion Criteria:\n\n* Cashew nut allergy confirmed prior to the initiation of immunotherapy\n* Completion of the first phase of the study, including achievement of the maintenance dose (1200 mg of cashew nut protein) during immunotherapy\n* Provision of informed consent for participation in the study\n* Adequate cooperation from the patient and\u002For their legal guardians\n\nExclusion Criteria:\n\n* Severe asthma\n* Poorly controlled mild-to-moderate asthma, defined as:\n\n  * FEV1 \\\u003C 80% (below the 5th percentile),\n  * FEV1\u002FFVC ratio \\\u003C 75% (below the 5th percentile),\n  * Hospitalization due to asthma exacerbation within the past 12 months\n* Oral, sublingual, or subcutaneous immunotherapy for other allergens during the first year\u002Fseason of therapy\n* Eosinophilic gastrointestinal disorders\n* Severe, recurrent episodes of anaphylaxis within the last 6 months\n* Chronic illnesses requiring ongoing treatment, including:\n\n  * Cardiac conditions\n  * Epilepsy\n  * Metabolic disorders\n  * Diabetes mellitus\n* Use of the following medications:\n\n  * Daily oral corticosteroid therapy \\>1 month within the past 12 months\n  * At least two courses of oral corticosteroids (minimum duration of 7 days each) in the past 12 months\n  * One course of oral corticosteroids (minimum 7 days) within the past 3 months\n  * Biologic therapies\n  * Treatment with β-blockers, ACE inhibitors, or calcium channel blockers\n* Pregnancy\n* Lack of informed consent for participation\n* Lack of cooperation from the patient","ALL","4 Years","17 Years",{"count":59,"type":60},39,"ESTIMATED","INTERVENTIONAL",[63],"NA","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:\n\n* First arm (initial experimental group) - patients will continue oral immunotherapy (OIT) with cashew nut protein (1200mg) for the next 8 months (+\u002F- 3 weeks).\n* 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 (+\u002F- 3 weeks).\n\nAfter an additional 8 months (+\u002F- 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).",[66],"Food Allergy in Children",[68],"food allergy, oral immunoteraphy, cashew nut allergy,","NOT_YET_RECRUITING","2025-09-04",{"date":72,"type":73},"2025-09-08","ACTUAL",{"date":75,"type":60},"2025-09",{"date":77,"type":60},"2029-05",{"name":5,"class":6},1]