[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tree-nut-allergies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tree-nut-allergies":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,77],{"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":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100651607","multi-food-oral-immunotherapy-for-peanut-and-tree-nuts-100651607",false,"NCT07764159","Multi-Food Oral Immunotherapy for Peanut and Tree Nuts","An Open-Label, Multicenter, Randomized Clinical Trial Evaluating the Efficacy and Safety of Oral Multi-Food Immunotherapy With Peanut and Tree Nuts Protein Mixtures","Inclusion Criteria:\n\n* Age 1-12 years;\n* Confirmed allergy to at least two allergens included in the protocol, i.e., peanut and\u002For tree nuts: cashew, walnut, hazelnut, and almond;\n* Positive skin prick test (SPT) (wheal diameter ≥ 3 mm) and\u002For specific IgE (sIgE) level \\> 0.35 kUA\u002FL for at least two of the analyzed allergens;\n* Positive OFC-1 (oral food challenge) of grade I-IV according to the WAO classification for at least two allergens, with a positive reaction occurring after administration of a dose ≥ 3 mg and ≤ 3000 mg of allergen protein;\n* Participants may be enrolled based on the abbreviated procedure as outlined in the study description;\n* Written informed consent obtained from a legal guardian, and, where applicable, assent from the child in accordance with their age and level of maturity;\n* Good prognosis for compliance and cooperation of the patient and their caregivers.\n\nExclusion Criteria:\n\n* Allergic reaction at the lowest challenge dose of 1 mg of allergen protein for any allergen, or no allergic reaction after administration of the maximum dose of 3000 mg of allergen protein for at least four of the analyzed allergens;\n* History of anaphylaxis with a grade V reaction according to the WAO classification, either during an oral food challenge or in the patient's medical history;\n* Severe asthma;\n* Poorly controlled asthma according to GINA 2025 (lack of symptom control and\u002For ≥2 exacerbations requiring systemic glucocorticoids or ≥1 exacerbation requiring hospitalization within the last 12 months), or in children able to perform spirometry: FEV1 \\\u003C -1.64 Z-score and\u002For FEV1\u002FFVC \\\u003C -1.64 Z-score;\n* Eosinophilic gastrointestinal disease;\n* Other chronic diseases requiring ongoing treatment which, in the investigator's opinion, may increase the risk associated with study participation or interfere with the interpretation of results, including severe cardiac disease, epilepsy, metabolic disorders, or diabetes;\n* Previous immunotherapy with food allergens;\n* Concurrent immunotherapy with aeroallergens;\n* Treatment with biologic agents, beta-blockers, ACE inhibitors, or calcium channel blockers;\n* Oral corticosteroid therapy meeting any of the following criteria: daily treatment for \\>1 month within the last 12 months; at least two courses lasting ≥7 days within the last 12 months; one course lasting ≥7 days within the last 3 months;\n* Lack of consent to participate in the study or insufficient cooperation of the patient and\u002For caregivers. In such cases, patients will receive standard medical care, including allergen avoidance and provision of emergency medication.\n\nWell-controlled asthma, allergic rhinitis, and atopic dermatitis are not exclusion criteria.","ALL","1 Year","12 Years",{"count":20,"type":21},39,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to evaluate the efficacy and safety of multi-food oral immunotherapy (multi-OIT) using peanut and tree nuts proteins in children with confirmed food allergy to at least two allergens. Participants will be randomized in a 2:1 ratio to receive either multi-OIT or standard management consisting of an elimination diet. The primary objective is to evaluate immunotherapy efficacy defined as achieving tolerance to a cumulative dose of 4444 mg of protein during an oral food challenge (OFC-2) for at least one allergen that elicited a reaction during baseline challenge (OFC-1), compared with the control group. Secondary outcomes include the proportion of participants tolerating multiple allergens at the target cumulative dose; the incidence, type, and severity of adverse events classified according to the World Allergy Organization (WAO) grading system; changes in immunological parameters, including allergen-specific IgE and IgG4 levels; changes in skin prick test responses; changes in the quality of life of patients and their families.",[27,28,29,30,31],"Food Allergies","Food Allergy in Children","Peanut Allergies","Tree Nut Allergies","Oral Immunotherapy for Food Allergy","NOT_YET_RECRUITING","2026-08-11",{"date":35,"type":36},"2026-08-13","ACTUAL",{"date":38,"type":21},"2026-09",{"date":40,"type":21},"2031-12",{"name":42,"class":43},"Medical University of Warsaw","OTHER",4,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100606053","phase-2-unc-cashew-sublingual-immunotherapy-100606053","NCT07170540","UNC Cashew Sublingual Immunotherapy","Cashew Allergy Study in Children: Assessing Desensitization, Efficacy, and Safety (CASCADES Study)","CASCADES","Inclusion Criteria:\n\n* Age 1-11 years at enrollment\n* Cashew allergy, with allergy defined as:\n* History of clinical reaction to cashew AND cashew-specific IgE \\>\u002F=0.35 kUA\u002FL AND cashew SPT \\>\u002F=3 mm\n* OR if no prior reaction, cashew-specific IgE \\>\u002F=5 kUA\u002FL AND cashew SPT \\>\u002F=3 mm\n* Positive Double-Blind Placebo Controlled Food Challenge (DBCPFC) to 443 mg cumulative cashew at enrollment\n* If female of child-bearing potential, must have a negative urine or serum pregnancy test\n* If female of childbearing potential (defined as females who have reached menarche or who are 12 years or older), must agree to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods (barrier methods or oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy) during the treatment period\n\nExclusion Criteria:\n\n* Inability or unwillingness of a participant and\u002For parent\u002Flegal guardian to give written informed consent and\u002For assent or comply with the study protocol\n* History of severe anaphylaxis to cashew defined as neurological compromise or requiring intubation\u002Fmechanical ventilation\n* Known oat, wheat, or glycerin allergy\n* Poorly controlled or severe asthma\u002Fwheezing at screening, defined by at least one of the following criteria:\n* Global Initiative for Asthma (GINA) 2024 criteria for uncontrolled asthma\n* History of 2 or more systemic corticosteroid courses within 6 months of screening or one course of systemic corticosteroids within 3 months of screening to treat asthma\u002Fwheezing\n* Prior intubation\u002Fmechanical ventilation for asthma\u002Fwheezing\n* Hospitalization or overnight Emergency Department (ED) visit for asthma\u002Fwheezing within 6 months of screening\n* Forced expiratory volume in one second (FEV1) \\\u003C80% of predicted or FEV1\u002Fforced vital capacity (FVC) \\\u003C75%, with or without controller medications (for participants \\>\u002F= 6 years and older, able to perform spirometry)\n* Peak expiratory flow rate (PEFR) \\\u003C80% of predicted for participants \\>6 and able to perform peak flow\n* Inhaled corticosteroid (ICS) dosing of \\>500 mcg daily fluticasone (or equivalent ICS)\n* Eosinophilic or other inflammatory (e.g., celiac) gastrointestinal disease\n* Inability to discontinue antihistamines at least 5 half-lives before scheduled SPT and DBPCFC\n* Food immunotherapy such as Oral Immunotherapy (OIT), Sublingual Immunotherapy (SLIT), or Epicutaneous (EPIT) for cashew or pistachio within 6 months of enrollment\n* Monoclonal antibodies such as omalizumab (Xolair), dupilumab (Dupixent), benralizumab (Fasenra), mepolizumab (Nucala), or other immunomodulatory therapy within 6 months of enrollment\n* Currently on dose escalation of environmental allergen immunotherapy (SCIT or SLIT). Individuals on maintenance allergen immunotherapy can be enrolled\n* Participation in any interventional study within the past 3 months\n* Pregnant or breastfeeding\n* Past or current medical condition or clinical significant laboratory abnormality that, in the opinion of the PI, would make the participant unsafe or otherwise unsuitable for participation in the clinical trial","11 Years",{"count":55,"type":21},45,[57],"PHASE2","The CASCADES study will investigate the safety and efficacy of sublingual immunotherapy (SLIT) for the treatment of cashew allergy in children ages 1-11 years old. Primary efficacy will be assessed after 18 months of cashew SLIT. Lab studies and an oral food challenge after 6 months of cashew SLIT will help determine how quickly cashew SLIT begins to take effect.",[60,30],"Cashew Nut Allergy",[62,63,64,65,66],"cashew allergy","tree nut allergy","food allergy","sublingual immunotherapy","SLIT","2026-04-13",{"date":69,"type":36},"2026-04-14",{"date":71,"type":21},"2026-06",{"date":73,"type":21},"2028-12",{"name":75,"class":43},"University of North Carolina, Chapel Hill",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":16,"minAge":17,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":76},"100223945","blood-samples-for-the-study-of-peanut-tree-nut-and-other-food-allergies-100223945","NCT02192866","Blood Samples for the Study of Peanut, Tree Nut and Other Food Allergies","Inclusion Criteria:\n\nThis protocol is to draw blood for a variety of related studies of food allergy. For this reason, we will list each group of subjects and the inclusion criteria for that group.\n\n1. De-identified sera or plasma from patients who have undergone Oral ImmunoTherapy (OIT) for peanut allergy. These samples already exist.\n\n   * Inclusion criteria:\n\n     1. patients have been enrolled in a controlled trial of OIT for peanuts, and had at least one oral challenge.\n     2. Age 1-75.\n2. De-identified samples from patients who are undergoing clinically indicated food challenges for peanut allergy.\n\n   * Inclusion criteria:\n\n     1. concern regarding possible allergy to peanuts,\n     2. age 1-75,\n     3. plan to undergo a clinically indicated challenge with peanuts.\n3. Patients with peanut allergy.\n\n   * Inclusion criteria:\n\n     1. excellent history of a systemic reaction to peanuts,\n     2. age 6-75.\n4. Patients with other food allergies (especially tree nuts).\n\n   * Inclusion criteria:\n\n     1. excellent history of a systemic reaction to tree nuts or other foods,\n     2. age 6-75.\n5. Normal controls.\n\n   * Inclusion criteria:\n\n     1. no known food allergies,\n     2. recent ingestion of peanuts without difficulty, and\n     3. age 6-75.\n\nExclusion Criteria:\n\n1. Any known significant medical or psychiatric diagnosis\n2. Use of an investigational drug within 30 days\n3. Use of omalizumab (anti-IgE; Xolair) within 6 months",true,"75 Years",{"count":86,"type":21},270,"OBSERVATIONAL","Food allergies are now a major problem. These experiments involve getting blood from people with food allergies and from people without food allergies. The blood collected will be used to answer questions and find information about peanut and other food allergies.\n\nSamples will come from:\n\n* People signed up by the investigators at the University of Colorado Denver\n* University of North Carolina, Massachusetts General Hospital, Children's Hospital of Colorado and the Immune Tolerance Network (Benaroya Research Institute) where people have been treated for peanut allergies\n* University of North Carolina, Massachusetts General Hospital, National Jewish Health and The Children's Hospital in Denver where people have taken part or will take part in clinically indicated oral food challenges.\n\nBlood and health histories from the University of North Carolina, Massachusetts General Hospital, National Jewish Health, The Children's Hospital and the Immune Tolerance Network will not have personal information linked.\n\nThe specific aims of this experiment are:\n\n1. Come up with a lab test that will predict how bad an allergic reaction will be to peanuts.\n2. Find out what part of a peanut causes allergic reactions.\n3. Come up with preventions that can block peanut allergies.\n4. Find the strongest proteins in walnuts.",[29,30,90],"Other Food Allergies","RECRUITING","2022-12-14",{"date":94,"type":36},"2022-12-19",{"date":96,"type":36},"2014-02",{"date":98,"type":21},"2030-12",{"name":100,"class":43},"University of Colorado, Denver"]