[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"food-allergy-in-children\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:food-allergy-in-children":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,46,70,109,147,171,193,213,242,270],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100640171","pathway-to-peanut-tolerance-100640171",false,"NCT07592780","Pathway to Peanut Tolerance","A Pragmatic, Open-label Study of Peanut Oral Immunotherapy in Inducing Desensitisation or Remission in Children With Food Allergy Compared to Standard Care (Strict Allergen Avoidance)","Inclusion Criteria:\n\n* Subject's parent and\u002F or guardian must be able to understand and provide informed consent.\n* Age 2 to 17 years of age\n* Either sex\n* Any race, any ethnicity\n* Have a history of sensitization \\[positive skin prick test to peanut extract as defined by wheal size at least 3mm above control OR peanut-specific IgE ≥0.35 kUA\u002FL\\]\n\nExclusion Criteria: Individuals who meet any of these criteria are not eligible for enrolment:\n\n* Any disorder in which adrenaline is contraindicated (such as hypertension or cardiac rhythm disorders)\n* History of chronic diseases requiring therapy (other than asthma, atopic dermatitis, allergic rhinitis)\n* Past or current major illness that in the opinion of the Site investigator may affect the subject's ability to participate in the study e.g. increased risk to the participant\n* Concurrent treatment with any allergen immunotherapy\n* Participation in any trials of therapeutic interventions for FA, or therapy with anti-IgE or other biologics within 1 year of enrolment\n* Current uncontrolled or moderate to severe asthma as defined by FEV1 value \\\u003C80% predicted for participants aged 7 years or older and are able to perform spirometry\n* Gastrointestinal eosinophilic disorders\n* Use of short-acting antihistamine (e.g. chlorpheniramine) within 3 days prior to open-labelled food challenge or skin testing, or medium-acting antihistamine (e.g. cetirizine, loratadine) within 5 days prior to open-labelled food challenge or skin testing\n* Use of beta-blockers, ACE inhibitors, angiotensin-receptor blockers or calcium channel blockers","ALL","2 Years","17 Years",{"count":20,"type":21},125,"ESTIMATED","INTERVENTIONAL",[24],"NA","While rigorous clinical trials have established peanut OIT as a promising therapy capable of inducing desensitization and even remission, its transition to routine clinical practice requires robust real-world evidence. Current management relies on strict avoidance, and the lack of reliable biomarkers to predict long-term success remains a significant barrier to the wider, more accessible application of OIT. Therefore, there is a critical need to evaluate peanut OIT in pragmatic, real-world settings. Such studies are essential to understand its effectiveness and safety beyond controlled trial conditions, to identify which patients benefit most, and to develop practical monitoring strategies. Generating this evidence is a crucial step toward making this treatment a viable and optimized option for the growing global population affected by peanut allergy.",[27,28],"Food Allergy in Children","Food Allergy Peanut",[30,31,32],"food allergy","peanut allergy","oral immunotherapy","RECRUITING","2026-05-15",{"date":36,"type":37},"2026-05-19","ACTUAL",{"date":39,"type":37},"2025-11-15",{"date":41,"type":21},"2029-12-31",{"name":43,"class":44},"Chinese University of Hong Kong","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":45},"100552046","phase-2-boiled-tree-nut-for-oral-immunotherapy-in-food-allergic-children-100552046","NCT06467994","Boiled Tree Nut for Oral Immunotherapy in Food-allergic Children","A Randomised, Controlled Trial Evaluating the Effectiveness of Boiled Cashew OraL immunoTherapy (BOLT) in Inducing Desensitisation or Remission in Children With Cashew Nut Allergy Compared With Placebo","Inclusion Criteria:\n\n* Aged between 2 year and 17 years of age;\n* Either sex, and of any race and ethnicity;\n* \\>7kg (the weight considered safe for the administration of an adrenaline autoinjector) (e.g. Jext);\n* Confirmed diagnosis of cashew nut allergy as defined by a failed DBPCFC with cashew nut and a positive SPT (\\>=3mm than control) or sIgE to cashew nut (of at least 0.35 kUA) at screening.\n* Subject's parent and\u002F or guardian must be able to understand and provide informed consent.\n\nExclusion Criteria:\n\n* History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three (3) doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)\n* Severe anaphylaxis during the study entry DBPCFC (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring more than 3 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)\n* Any disorder in which adrenaline is contraindicated (such as hypertension or cardiac rhythm disorders)\n* Reacting to the placebo component during the study entry DBPCFC\n* FEV1 \\\u003C85% at rest and FEV1\u002FFVC ≤ 85% at rest or ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines)\n* Underlying medical conditions (e.g. cardiac disease) that increase the risks associated with anaphylaxis\n* Use of beta-blockers, ACE inhibitors or calcium channel blockers\n* Inflammatory intestinal conditions, indwelling catheters, gastrostomies, immune-compromised states, post-cardiac and\u002For gastrointestinal tract surgery, critically-ill and those requiring prolonged hospitalisation or other conditions that may increase the risks of probiotic associated sepsis\n* Have received other food immunotherapy treatment in the preceding 6 months\n* Currently taking immunomodulatory therapy (including allergen immunotherapy)\n* Therapy with anti-IgE or other biologics within 1 year of enrolment\n* Past or current major illness that in the opinion of the Site Investigator may affect the subject's ability to participate in the study e.g. increased risk to the participant\n* History of suspected or biopsy-confirmed eosinophilic oesophagitis (EoE)\n* Subjects who in the opinion of the Site Investigator are unable to follow the protocol NOTE: participants with other food allergies are NOT excluded from participating in this trial.",{"count":54,"type":21},75,[56],"PHASE2","As the global prevalence of food allergy steadily increases, tree nut (TN) becomes one of the main triggers of food-allergic reactions and food anaphylaxis. Since there is no effective cure, TN-allergic patients and their families must continue to live with this chronic, disabling condition while avoiding allergens and responding to allergic reactions with emergency treatment. An emerging experimental treatment for food allergy is oral immunotherapy (OIT). Tree nut OIT appears promising in preliminary studies but there are concerns about the high risk of adverse reactions to TNs used in the treatment. The rate of remission with TN OIT is also lacking. Identification of OIT regimes with increased efficacy and safety is urgently needed. The investigators revealed that boiled cashews had lower allergenic potential but retained mast cell reactivity. The aim of this proposed study is to investigate the efficacy and safety of a novel treatment strategy for TN-allergic individuals, whereby the investigators hypothesized that consuming increasing quantities of boiled cashews can induce desensitization\u002F remission to roasted tree nuts in children with cashew allergies.",[27,59],"Food Allergy",[30,61,62,32],"cashew allergy","tree nuts","2026-05-12",{"date":34,"type":37},{"date":66,"type":37},"2024-06-01",{"date":68,"type":21},"2028-06-30",{"name":43,"class":44},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":18,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":45},"100625177","phase-1-tolerance-results-and-immune-mechanisms-in-cows-milk-andor-hens-egg-allergic-children-following-natural-evolution-or-oral-immunotherapy-100625177","NCT07419243","Tolerance Results and Immune Mechanisms in Cow´s Milk and\u002For Hen´s Egg Allergic Children Following Natural Evolution or Oral Immunotherapy","Identification of Mechanisms and Biomarkers Predictive of Tolerance in Children With Food Allergies: Comparison Between Treatment With Oral Immunotherapy and Natural Evolution. alerITO Study","alerITO","Inclusion Criteria:\n\nNAT-cohort:\n\n* Cow´s Milk and\u002For Hen´s Egg allergic patients 4 to 10 years old\n* sIgE levels to milk OR egg extracts between 0.35 to 35kUA\u002FL\n* Positive entry Open food challenge with milk\u002Fegg with oFASS5 classification ≥2 with a maximum cumulative dose of up to 4193.7 mg of milk protein or 3110.8 mg of egg white protein\n* Having a mild to moderate food allergy severity per the Definition of Food Allergy Severity (DEFASE) score (\\\u003C13 points)\n* Having signed the informed consent\n\nOIT-cohort:\n\n* Patients in the compITO study (NCT06976775) who are undergoing OIT and have achieved full desensitization to the food by month 7 of the study (end of study)\n* Patients in the compITO study who are undergoing OIT and have achieved partial desensitization (tolerating a dose lower than the total dose, and a minimum of 3 doses above the entry challenge threshold) to the food by month 7 of the study (end of study)\n* Having signed the informed consent\n\nExclusion Criteria:\n\nNAT-cohort:\n\n* Positive reaction in the entry open oral food challenge with a baseline Eliciting Dose (ED) 20 below the target ED20 for food. For milk, 23.1 mg (35.7 mg cumulative) of protein, or for egg, 19.5 mg (29.4 mg cumulative) of protein.\n* Patient desire or medical indication to initiate OIT at any time within 29 months of study entry.\n* No allergic reaction greater than oFASS5 grade 1 in the baseline challenge for the maximum cumulative programmed doses of 4193.7 mg of milk protein, or 3110.8 mg of egg white protein.\n* Immunological diseases, immunomodulatory\u002Fblocking therapies.\n* Severe atopic dermatitis according to the SCORing Atopic Dermatitis (SCORAD) classification\n* Severe allergy, according to a DEFASE score ≥13\n* Spirometry values with moderate-to-severe airflow obstruction (FEV1 \\\u003C70%)\n* Poorly controlled asthma according to clinical criteria\n* Previous OIT for another food\n* Within the first 3 months of treatment with Subcutaneous Aeroallergen Immunotherapy\n* Within the first week of treatment with Sublingual Aeroallergen Immunotherapy\n* Presence or suspicion of Eosinophilic Esophagitis\n* Non-IgE-mediated allergy to milk or egg\n* Pregnancy\n* Significant medical comorbidities (renal, hepatic, or cardiac insufficiency, active infectious diseases, previous or concurrent cancers)\n* Inability to provide informed consent\n* Communication or cognitive barriers that prevent adherence to the protocol\n\nOIT-cohort:\n\n* Patients enrolled in the compITO study who have failed or withdrawn from the study for any reason.\n* Patients with uncontrolled Atopic Dermatitis or Asthma at the time of enrolment, or who have developed Eosinophilic Esophagitis.\n* Patients with confirmed pregnancy at the time of enrolment.\n* Patients who have developed significant medical comorbidities (renal, hepatic, or cardiac insufficiency, active infectious diseases, previous or concurrent cancers) at the time of enrolment.\n* Inability to provide informed consent.\n* Communication or cognitive barriers that prevent adherence to the protocol.","4 Years",{"count":80,"type":21},68,[82,56],"PHASE1","Allergy to Cow's milk and hen´s egg proteins are the most common causes of food allergies in early childhood and are associated with the occurrence of adverse events that may be life-threatening, quality of life impairment and negative nutritional and health economic impact.\n\nHowever, contrarily to other food allergy models such as nuts\u002Fpeanut allergy, milk and egg allergy have greater chances of natural resolution. While around 50% of children may outgrow milk or egg allergy by the age of 5 years old, only 22% of peanut allergic children at the age of 4 years can tolerate this food. However, it is also documented that, at 14 years of age, the persistence of milk and egg allergy still affects around 30% of these children.\n\nStandard of care relies on food avoidance and treatment of accidental reactions, but this approach is unsatisfactory because adverse events and quality of life limitations still remain. Milk and egg Oral Immunotherapy (OIT) is the most promising therapeutic alternative and showed good results to induce Desensitization (ability to tolerate the food while it is regularly taken) but insufficient efficacy to achieve Sustained Unresponsiveness (SU) (ability to tolerate the food after a period of avoidance).\n\nIn the day-to-day practice, families and allergists of milk and egg allergic children frequently face the following dilemma: what is the best approach? Keep waiting for natural resolution or embarking in OIT? At the moment, there are only very limited data to guide this decision, specially in children with mild to moderate allergy, that still after 6 years of age withhold relevant chances of naturally outgrowing their allergy.\n\nOur objective is conducting a longitudinal cohort-study of children undergoing food avoidance and children undergoing OIT to assess biomarkers of natural allergy resolution\u002Fpersistence and OIT Desensitization\u002FSustained Unresponsiveness trajectories.",[27],[86,87,88,89,90,91,92,93,94,95,96,97,98,99],"Oral immunotherapy","Food allergy","Children","Hen´s egg allergy","Cow´s milk allergy","Desensitization","Sustained Unresponsiveness","Biomarkers","Natural evolution","Microbiota","OIT","Quality of Life","FAQLQ","Burden of treatment","2026-02-25",{"date":102,"type":37},"2026-02-27",{"date":104,"type":37},"2026-02-18",{"date":106,"type":21},"2030-07-30",{"name":108,"class":44},"Fundación de Investigación Biomédica - Hospital Universitario de La Princesa",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":45},"100591157","phase-2-comparison-between-a-rush-and-a-conventional-oral-immunotherapy-protocol-to-treat-cows-milk-and-hens-egg-allergy-compito-study-100591157","NCT06976775","Comparison Between a Rush and a Conventional Oral Immunotherapy Protocol to Treat Cow's Milk and Hen´s Egg Allergy. CompITO Study","Comparative Analysis Between Two Oral Immunotherapy Schemes in Cow´s Milk and\u002For Hen´s Egg Allergic Children to Improve Treatment Efficiency and Identify Response Biomarkers. CompITO Study","compITO","Inclusion Criteria:\n\n* Patients 6 to 16 years old\n* sIgE levels to milk 0.35 to 35kUA\u002FL for milk allergic subjects and egg 0.35 to 35kUA\u002FL for egg allergic subjects\n* Entry DBPCFC discrete milk eliciting dose (ED)≥ 22.2mg of milk protein and discrete egg ED≥18.5mg of egg protein, that are the population-based reference values for the ED20\n* Having a mild to moderate food allergy severity per DEFASE score (\\\u003C13 points)\n\nExclusion Criteria:\n\n* sIgE levels to milk \\>35kUA\u002FL for milk allergic subjects and egg \\> 35kUA\u002FL for milk allergic subjects\n* Entry DBPCFC discrete milk ED\\\u003C22.2mg of milk protein or discrete egg ED\\\u003C18.5mg of egg protein\n* Entry DBPCFC discrete ED for milk\\>2112mg of milk protein (cumulative amount of 4193,7mg of milk protein) and egg discrete ED\\>1560mg of egg protein (cumulative amount of 3110.8mg of egg protein)\n* Having severe food allergy per DEFASE score (≥13 points)\n* Other exclusion criteria: uncontrolled asthma, FEV1\\\u003C70%, severe atopic dermatitis, Eosinophilic Esophagitis, non-IgE mediated allergy, having started SCIT 3 months before, or SLIT one week before. Pregnancy","6 Years","16 Years",{"count":120,"type":21},40,[56,122],"PHASE3","This study investigates the efficacy and safety of two different OIT schemes to treat milk and egg allergic children",[27,125,126],"Milk Allergy","Egg Allergy",[128,129,130,131,86,132,133,134,135,136,87,137,88,138],"Food immunotherapy","Allergy","Milk","Egg","Anaphylaxis","Mast cell activation test","Saliva","Blood","IgE","Sensitization","Pediatric","2026-02-16",{"date":104,"type":37},{"date":142,"type":37},"2025-06-03",{"date":144,"type":21},"2027-04-30",{"name":146,"class":44},"Pablo Rodríguez del Rio",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":18,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":45},"100605138","sustained-unresponsiveness-su-to-cashew-nut-protein-following-oral-allergen-specific-immunotherapy-100605138","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",{"count":155,"type":21},39,[24],"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).",[27],[160],"food allergy, oral immunoteraphy, cashew nut allergy,","NOT_YET_RECRUITING","2025-09-04",{"date":164,"type":37},"2025-09-08",{"date":166,"type":21},"2025-09",{"date":168,"type":21},"2029-05",{"name":170,"class":44},"Medical University of Warsaw",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":178,"maxAge":18,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":192,"locationsCount":45},"100601204","sustained-unresponsiveness-su-to-sesame-protein-following-low-dose-oral-allergen-specific-immunotherapy-100601204","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.","3 Years",{"count":155,"type":21},[24],"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).",[27],[184,32,185],"sesame allergy","sustained unresponsiveness (SU)","2025-08-01",{"date":188,"type":37},"2025-08-06",{"date":190,"type":21},"2025-08",{"date":168,"type":21},{"name":170,"class":44},{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":202,"phases":4,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":45},"100601082","the-role-of-nichel-and-ltps-sensitization-in-functional-gastrointestinal-disorders-the-nilt-study-100601082","NCT07105865","The Role of NIchel and LTPs Sensitization in Functional Gastrointestinal Disorders: the NILT Study","Inclusion Criteria:\n\n* Age at least of 4 years\n* both sexes\n* history of functional dyspepsia (according to the Rome IV criteria, at least one symptom among the following - duration of symptoms greater than 4 days per month and for more than 2 consecutive months, feeling of post-prandial fullness, early satiety, pain and\u002For epigastric burning not associated with defecation - in the absence of organic disease) and irritable bowel syndrome (according to the Rome IV criteria, including all of the following criteria for at least 2 months prior to diagnosis - abdominal pain for at least 4 days per month associated with one\u002Fmore of the following: change in EF, change in stool shape\u002Fappearance, if constipation is noticed, pain does not resolve with resolution of constipation - in the absence of organic disease).\n* written informed consent from the parents of the participants and the participants if over 6 years of age.\n\nExclusion Criteria:\n\n* Age \\\u003C 4 years\n* Evidence of gastrointestinal pathology of organic nature (GERD, Helicobacter Pylori infection, eosinophilic diseases, celiac disease, chronic inflammatory bowel disease, chronic pancreatitis, cholelithiasis, neoplasia); motility disorder on a post-infectious basis; food intolerances (e.g. lactose), carbohydrate malabsorption, use of ASAs, NSAIDs; chronic systemic diseases (diabetes, amyloidosis, neuropathy) and autoimmune diseases; neuropsychiatric disorders; pregnancy.","65 Years",{"count":201,"type":21},100,"OBSERVATIONAL","Non-specific lipid transfer proteins (nsLTPs) are currently recognized as the most prevalent cause of primary IgE-mediated food allergy in Mediterranean populations and constitute a leading trigger of anaphylactic reactions. In Italy, the prevalence of LTP sensitization is estimated at 2-2.4% in adults and approximately 9% in children, with marked geographic variation. Specifically, higher prevalence rates are observed in central and southern regions and on the islands (21.3%-27.2%) compared to the northern regions (approximately 11%).\n\nLTPs are ubiquitous panallergens, widely expressed throughout the plant kingdom. They represent the major allergens within the Rosaceae family in individuals not sensitized to birch pollen and have also been identified and characterized in numerous plant-derived foods, including nuts, legumes, rice, maize, beer, spelt, and wheat. The clinical spectrum of LTP hypersensitivity is highly heterogeneous. While a significant proportion of sensitized individuals remain asymptomatic, others may present with localized reactions such as contact urticaria or oral allergy syndrome (OAS). More severe cases may involve gastrointestinal symptoms (e.g., vomiting, epigastric discomfort, abdominal pain), cutaneous and respiratory manifestations, and systemic responses up to anaphylactic shock.\n\nNickel is a ubiquitous metal employed in a wide range of industrial applications and consumer products, including stainless steel, metal plating, various alloys, and inexpensive jewelry. It is also naturally present in both animal and plant-based food sources (e.g., cereals, cocoa, legumes, fresh fruits and nuts, fish). Nickel is the most common sensitizer in allergic contact dermatitis, affecting approximately 20% of the general population and around 10% of the pediatric population. Sensitization to nickel involves a delayed-type (Type IV) hypersensitivity reaction and is not IgE-mediated. Clinical manifestations range from localized allergic contact dermatitis to systemic involvement, referred to as systemic nickel allergy syndrome (SNAS), which is characterized predominantly by gastrointestinal symptoms, although respiratory and other systemic manifestations can also occur.\n\nGastrointestinal symptoms such as gastroesophageal reflux disease (GERD), functional dyspepsia, abdominal pain, and altered bowel habits, when not associated with overt allergic signs or underlying organic disease, are typically classified as functional gastrointestinal disorders (FGIDs). Several studies report that up to 40% of adult patients with FGIDs exhibit nickel sensitization; however, data in the pediatric population remain scarce.\n\nChelanik® is a dietary supplement designed to support individuals with nickel hypersensitivity. It contains bioactive components purported to exert immunomodulatory and anti-inflammatory effects. Nevertheless, in vitro human data directly demonstrating its activity on lymphocyte function are currently lacking.\n\nThis prospective, experimental, single-center study aims to determine the prevalence of sensitization to LTP and nickel among patients presenting with functional dyspepsia or irritable bowel syndrome (IBS), and to assess in vitro the potential immunomodulatory effects of Chelanik® on peripheral blood lymphocytes from individuals with nickel allergy.",[27],"2025-07-29",{"date":188,"type":37},{"date":208,"type":37},"2025-07-01",{"date":210,"type":21},"2027-07-01",{"name":212,"class":44},"Federico II University",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":220,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":225,"conditions":226,"keywords":227,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":45},"100518756","evaluation-of-the-food-allergy-mastery-program-100518756","NCT06034678","Evaluation of The Food Allergy Mastery Program","Evaluation of a Behavioral Intervention to Promote Food Allergy Self-Management Among Early Adolescents: The Food Allergy Mastery Program","Inclusion Criteria:\n\n1. age 10-14 years\n2. physician diagnosis (i.e., history of a reaction to the food and\u002For recent positive skin prick test or IgE-specific testing) of at least 1 of the 9 most common IgE-mediated food allergies (peanut, tree nut, cow's milk, egg, soy, wheat, shellfish, fish, sesame) for ≥1 year, with accompanying allergen avoidance prescribed by an allergist\n3. English fluency\n4. access to a device with internet access\n5. either a food allergy knowledge score of \\\u003C80% correct on the Food Allergy Knowledge Test (FAKT) or a food allergy impact score of ≥3 on the Food Allergy Independent Measure (FAIM).\n\nExclusion Criteria:\n\n1. diagnosis of a non-IgE-mediated food allergy or food intolerance, a non-atopic chronic illness or pervasive developmental disorder\u002Fcognitive limitation\n2. Current participation in psychotherapy with a therapist with food allergy expertise","10 Years","14 Years",{"count":223,"type":21},240,[24],"The proposed research project will evaluate a novel behavioral intervention that promotes early adolescent food allergy self-management and adjustment through 1) food allergy education, 2) problem-solving, communication, assertiveness, and anxiety management skill building, and 3) peer support.",[27],[30,228,229,230,231,232],"knowledge","management","adolescents","caregivers","social support","2025-07-08",{"date":235,"type":37},"2025-07-11",{"date":237,"type":37},"2023-06-26",{"date":239,"type":21},"2027-11-30",{"name":241,"class":44},"Children's National Research Institute",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":202,"phases":4,"briefSummary":253,"conditions":254,"keywords":257,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":4},"100592632","improving-diagnosis-of-legume-allergy-in-children-100592632","NCT06995950","Improving Diagnosis of Legume Allergy in Children","Legume Allergy in Children: Improving Diagnosis Through the Development of Molecular Allergy Testing","LACID","Inclusion Criteria:\n\n* Sensitised to lupine, fenugreek or pea\n\nExclusion Criteria:\n\n* on going anti-IgE treatment or in the last 6 months","18 Years",{"count":252,"type":21},90,"In France, almost 15% of serious food allergies in children are caused by legumes, especially peanuts. Other legumes like soy, lentils, peas, lupin, chickpeas, beans, and fenugreek can also cause allergic reactions.\n\nBut here's the problem: only peanuts, soy, and lupin are required to be clearly labeled on food packaging in the European Union. This makes it hard for families to know when other legumes-like peas or fenugreek-are hidden in processed foods.\n\nAvoiding all these legumes is hard-especially since many of them are used in processed foods and not always listed on the label. Right now, detailed allergy tests to evaluate the probability of allergy diagnosis are only available for peanuts and soy, and not for other legumes.\n\nLACID study has been created to find and study the proteins in lupin, fenugreek, and peas that may cause allergies and developp better allergy tests for these legumes-possibly as part of a diagnostic tool that can give clear results using just a blood sample.\n\nThe goal is to help doctors and families better understand which legumes a child really needs to avoid-and which ones are actually safe to eat.",[27,255,256],"Legumes Allergy","Molecular Diagnostic",[30,258,259,260],"legume","children","molecular allergology","2025-06-02",{"date":263,"type":37},"2025-06-05",{"date":265,"type":21},"2025-06-01",{"date":267,"type":21},"2026-12",{"name":269,"class":44},"Central Hospital, Nancy, France",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":276,"sex":16,"minAge":277,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":282,"conditions":283,"keywords":284,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":291,"locationsCount":45},"100563653","phase-4-effect-of-omalizumab-in-the-skin-of-food-allergy-patients-100563653","NCT06618963","Effect of Omalizumab in the Skin of Food Allergy Patients","Inclusion Criteria:\n\n* Participant and\u002For parent\u002Flegal guardian must be able to understand and provide informed consent and\u002For assent, as applicable.\n* Male or female, 1-55 years old at screening.\n* Total IgE level within 1 year of screening and weight at screening visit that together result in an eligible omalizumab dose according to the dosing table for FA (Appendix 8).\n* Participant must meet the following clinical FA criteria: Food sensitization to peanut, hen's egg, a tree nut, sesame seed, cow's milk, wheat, or soy, within 1 year of screening AND experience dose-limiting, IgE mediated symptoms at or before 444mg of food protein cumulatively during screening OFC to peanut, hen's egg, a tree nut, sesame seed, cow's milk, wheat, or soy.\n* If female of child-bearing potential, must have a negative urine or serum pregnancy test. If participating as a healthy control, self-report of pregnancy status is acceptable.\n* For women of child-bearing potential, 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 and for 60 days after the last dose of study drug.\n* Be willing to be trained on the proper use of an epinephrine autoinjector and be willing to always have epinephrine autoinjector immediately available for the duration of the study.\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* Clinically significant laboratory abnormalities at Screening.\n* Sensitivity or suspected\u002Fknown allergy to any ingredients (including excipients) of the active OFC material (other than the study food), or drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin).\n* Poorly controlled AD at Screening, per the PI's discretion.\n* Poorly controlled or severe asthma\u002Fwheezing at Screening\n* History of severe anaphylaxis (defined as neurological compromise or requiring intubation) to a study food that is to be used for qualifying OFC in this study.\n* Treatment with oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma\u002Fwheezing within 30 days of Screening.\n* Currently receiving oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers (oral or topical).\n* Past or current history of cancer, or currently being investigated for possible cancer.\n* Previous adverse reaction to omalizumab.\n* Past or current history of any immunotherapy to the OFC food (e.g., oral immunotherapy \\[OIT\\], sublingual immunotherapy \\[SLIT\\], or patch\u002Fepicutaneous immunotherapy \\[EPIT)\\] within 4 months of Screening.\n* Treatment with monoclonal antibody therapy, such as omalizumab (Xolair®), dupilumab (Dupixent®), benralizumab (Fasenra™), mepolizumab (Nucala®), reslizumab (Cinqair®), or other immunomodulatory therapy within four months of Screening.\n* Currently on \"build-up phase\" of inhalant allergen immunotherapy (i.e., has not reached maintenance dosing). Individuals tolerating maintenance allergen immunotherapy can be enrolled.\n* Inability to discontinue antihistamines for the minimum wash-out periods required for SPTs or OFCs\n* Current participation in another therapeutic or interventional clinical trial or participation within 90 days of Screening.\n* Use of investigational drugs within 24 weeks of Screening.\n* Pregnant or breastfeeding or intending to become pregnant during the study or within 60 days after the last dose of omalizumab.\n* Have any skin disease other than AD that might compromise the stratum corneum barrier.\n* History of serious life-threatening reaction to tape or adhesives.\n* Healthy Control Participants (non-Food Allergy participants) may not have atopic dermatitis, autoimmune, or other conditions which, in the opinion of the PI, could confound the results of the study assessments or samples.",true,"1 Year","55 Years",{"count":120,"type":21},[281],"PHASE4","The goal of this interventional study is to evaluate whether skin barrier abnormalities occur in subjects with a food allergy, as determined by positive oral food challenge (OFC). The main question it aims to answer is whether these skin barrier abnormalities can be reversed by omalizumab.\n\nIf there is a comparison group: Researchers will compare non-food allergic participants (who do not receive omalizumab) to see if they experience skin barrier abnormalities.\n\nAll food allergic participants will receive 4 months of Omalizumab treatment as well as two Oral Food Challenges. Participants will all undergo skin barrier assessments.",[59,27],[59],"2025-04-29",{"date":287,"type":37},"2025-05-02",{"date":289,"type":37},"2024-10-01",{"date":267,"type":21},{"name":292,"class":44},"National Jewish Health"]