[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601204":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":71,"whyStopped":24,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Medical University of Warsaw","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Maintenance dose of sesame protein (300mg) 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 sesame protein (300mg) for the next 8 months.",[13],"Dietary Supplement: OIT with low dose sesame protein",{"label":15,"type":10,"description":16,"interventionNames":17},"Immunotherapy initiated after one year of sesame avoidance","Patients assigned to the control group in the first part of the study, after one year on a sesame 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 low dose sesame protein","After 8 months of continued low-dose sesame OIT, patients will undergo hospital-based assessments, including skin prick testing, laboratory evaluations, and an open Oral Food Challenge (OFC) to evaluate desensitization.\n\nPatients who had a negative OFC after 3 months in the initial phase of the study-and thus confirmed desensitization-will skip the pre-break OFC and proceed directly to the next stage.\n\nFollowing a 4-week interruption in OIT, patients will return for a final hospital visit, during which a concluding OFC will be conducted to assess sustained unresponsiveness. Additional laboratory tests and skin prick testing will also be performed at 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","100601204","sustained-unresponsiveness-su-to-sesame-protein-following-low-dose-oral-allergen-specific-immunotherapy-100601204",false,"NCT07107451","Sustained Unresponsiveness (SU) to Sesame Protein Following Low-dose Oral Allergen-specific Immunotherapy","Evaluation of the Acquisition of Sustained Unresponsiveness (SU) to Sesame Protein Following Low-dose Oral Immunotherapy - Long-term Follow-up of Patients From the RCT Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients, NCT06261554.","Inclusion criteria:\n\n* Sesame allergy confirmed before starting immunotherapy\n* Completion of the first part of the study - achieving the maintenance dose (300mg sesame protein) during immunotherapy\n* Obtaining informed consent to participate in the study,\n* Patient\u002Fcarer cooperation.\n\nExclusion criteria:\n\n* Severe asthma,\n* Mild\u002Fmoderate poorly controlled asthma: FEV1\\\u003C80% (under 5. percentile), FEV1\u002FFVC\\\u003C75% (under 5. percentile), hospitalisation for asthma exacerbation in the last 12 months,\n* Oral\u002Fsublingual\u002Fsubcutaneous immunotherapy against other allergens in the first year\u002Fseason of immunotherapy\n* Eosinophilic gastroenteritis,\n* Severe, recurrent episodes of anaphylaxis within the last 6 months,\n* Chronic diseases requiring ongoing treatment, including heart disease, epilepsy, metabolic diseases, diabetes,\n* Taking medication:\n\n  * oral, daily steroid therapy \\>1 month in the past 12 months,\n  * At least two courses of oral steroid therapy (at least 7 days) within the last 12 months,\n  * One oral steroid therapy (min. 7 days) in the last 3 months,\n  * biological treatment,\n  * therapy with β-blockers, ACE-inhibitors, calcium channel inhibitors,\n* Pregnancy,\n* No consent to participate in the study,\n* Lack of cooperation from the patient.\n\nWell-controlled asthma, allergic rhinitis, atopic dermatitis are not considered exclusion criteria.","ALL","3 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 and Safety of Low-Dose Sesame Oral Immunotherapy in Pediatric Patients\", NCT06261554. 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 low dose of sesame protein (300mg) for the next 8 months (+\u002F- 3 weeks).\n* Second arm (initial control group - one year on a sesame 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",[68,69,70],"sesame allergy","oral immunotherapy","sustained unresponsiveness (SU)","NOT_YET_RECRUITING","2025-08-01",{"date":74,"type":75},"2025-08-06","ACTUAL",{"date":77,"type":60},"2025-08",{"date":79,"type":60},"2029-05",{"name":5,"class":6},1]