[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urticaria-chronic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urticaria-chronic":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100651746","mediterranean-and-low-histamine-diets-for-pediatric-chronic-spontaneous-urticaria-100651746",false,"NCT07765979","Mediterranean and Low-Histamine Diets for Pediatric Chronic Spontaneous Urticaria","The Effects of the Mediterranean and Low-Histamine Diets on Disease Severity in Pediatric Chronic Spontaneous Urticaria","Inclusion Criteria:\n\n* Age 12-18 years. Confirmed diagnosis of Chronic Spontaneous Urticaria (CSU) according to international guidelines.\n\nNo recent use of systemic corticosteroids or immunosuppressive therapy (except short-term acute use).\n\nWritten informed consent provided by both the participant and a parent\u002Flegal guardian.\n\nExclusion Criteria:\n\n* Presence of a neurodevelopmental disorder. Presence of any other known chronic disease. Presence of a disease requiring a special therapeutic diet. Presence of an acute infection. Presence of any food allergy. Recent use of systemic corticosteroids, biologic agents, immunosuppressive therapy, or high-dose antihistamines (except short-term acute use).","ALL","12 Years","18 Years",{"count":20,"type":21},63,"ESTIMATED","INTERVENTIONAL",[24],"NA","Chronic spontaneous urticaria (CSU) is a chronic inflammatory skin disease that can substantially impair quality of life in children and adolescents. Pharmacological treatment may not adequately control symptoms in all patients, increasing interest in dietary interventions. This randomized controlled trial aims to compare the effects of a Mediterranean diet and a low-histamine diet, in addition to standard medical treatment, on disease activity, disease control, and quality of life in pediatric patients aged 12-18 years with chronic spontaneous urticaria. Participants will be allocated to one of three groups: standard treatment alone, standard treatment plus a low-histamine diet, or standard treatment plus a Mediterranean diet. The dietary intervention will last four weeks, with follow-up through eight weeks.",[27],"Urticaria Chronic",[29,30,31,32,33],"Chronic Urticaria","Mediterranean Diet","diet","histamine","Adolescent","RECRUITING","2026-08-10",{"date":37,"type":38},"2026-08-14","ACTUAL",{"date":40,"type":38},"2025-11-23",{"date":42,"type":21},"2027-01-15",{"name":44,"class":45},"Saglik Bilimleri Universitesi","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100587408","phase-2-an-outpatient-study-of-the-efficacy-of-ars-2-in-patients-with-chronic-spontaneous-urticaria-100587408","NCT06927999","An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria","An Outpatient, Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria","Inclusion Criteria:\n\n* Is a male or female between the ages of 18 and 65 years, inclusive.\n* Has been clinically diagnosed with CSU and experiences an acute flare of moderate to severe urticaria symptoms (itch and hive severity UAS score ≥ 2) approximately 1-2 times a month or every other month consistently during the past year while on a chronic treatment.\n* Has been on a daily chronic treatment for ≥ 6 weeks.\n* Is willing to use a smartphone study application to record study assessments and AEs.\n* Has body weight more than 15 kilogram (kg).\n* Has no medical history of clinically significant hypertension and cardiovascular disease in the last 10 years\n* If female, is not pregnant or breastfeeding based on a negative urine pregnancy test at baseline.\n* Is able to communicate clearly with the Investigator and staff; able to read, complete questionnaires, and perform study procedures on the smartphone study application.\n* Is willing and able to provide written informed consent prior to participating in the study.\n* Controlled hypertension without beta blocker confirmed by the Investigator is acceptable.\n* At screening, has stable vital signs in the following ranges (after 5 minutes of rest):\n\n  * Systolic blood pressure (SBP) ≥90 and ≤140 milliliters of mercury (mmHg)\n  * Diastolic blood pressure (DBP) ≥50 and ≤90 mmHg\n  * Heart rate (HR) ≥45 and ≤100 beats per minute (bpm)\n\nExclusion Criteria:\n\n* Has a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.\n* Has any clinically significant medical condition or PE finding as deemed inappropriate by the Investigator.\n* Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram (ECG)\n* Has had significant traumatic injury or major surgery within 30 days prior to study screening.\n* Known hypersensitivity to any compound in the test product, or any other closely related compound (e.g., dihydropyridine-derived molecules).\n* Has participated in a clinical trial within 30 days prior to the first dose of study drug.\n* Has an immediate family member of the Investigator, or an employee of the study center, with direct involvement in the proposed study, or other studies under the direction of the Investigator or study center or is in a dependent relationship with a study center employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress.","65 Years",{"count":56,"type":21},42,[58],"PHASE2","This is a Phase 2b, outpatient, single-dose, randomized, double blind, placebo-controlled, three period crossover study that will consist of a screening period and three blinded treatment periods. Subjects enrolled will have CSU with a history of moderate to severe acute exacerbations (or flares).",[27],"2026-07-21",{"date":63,"type":38},"2026-07-22",{"date":65,"type":38},"2025-07-09",{"date":67,"type":21},"2027-06",{"name":69,"class":70},"ARS Pharmaceuticals, Inc.","INDUSTRY",3]