[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"food-allergy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:food-allergy":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,46,71,87,124,153,177,227,253,291,312,338,367,390,415,441,465,490,519,541,563,584,609,632,656],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100247843","natural-history-and-genetics-of-food-allergy-and-related-conditions-100247843",false,"NCT02504853","Natural History and Genetics of Food Allergy and Related Conditions","* GENERAL INCLUSION CRITERIA:\n\nAll participants must meet the following criteria:\n\n1. Be 2 to 99 years-old at the time of enrollment for participants who will be seen at the NIH CC; be 0 (newborn) to 99 years-old at the time of enrollment for participants who will submit mail-in samples or participate in telehealth visits. Only viable neonates will be enrolled.\n2. Willing to allow storage of blood, buccal swabs, saliva, nasal swabs, stool samples, and other clinically appropriate tissue specimens for future use in medical research\n3. Required to have a primary care or other physician who will manage all health conditions related or unrelated to the study objectives\n\nADDITIONAL INCLUSION CRITERIA FOR AFFECTED PARTICIPANTS\n\nIn addition to the general criteria listed above, affected participants must meet 1 of the following criteria:\n\n1. Have a clinical history of an immediate hypersensitivity reaction to food(s) and be sensitized to food allergen(s) (as evidenced by positive SPT or allergen-specific IgE testing)\n2. Be sensitized (as evidenced by positive SPT or allergen-specific IgE testing) to food allergen(s) but have no overt clinical history of IgE-mediated symptoms when they eat that food(s)\n3. Have a suspected genetic or congenital disorder potentially associated with food allergy or related condition, as determined by the principal investigator (PI) or associate investigators (AIs)\n4. Have a diagnosis of eosinophilic esophagitis (EoE), or clinical suspicion for EoE as determined by the principal investigator (PI) or associate investigators (AIs)\n5. Have a history of atopic dermatitis based on self-report or physician assessment.\n\nADDITIONAL INCLUSION CRITERIA FOR UNAFFECTED RELATIVES:\n\nIn addition to the general criteria listed above, unaffected relatives must meet the following criteria:\n\n1. Be a relative of an affected participant\n2. Be unaffected by food allergy (as determined by clinical history and\u002For allergy testing) or be unaffected by the genetic condition under study\n\nADDITIONAL INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS\n\nIn addition to the general criteria listed above, healthy volunteers must meet the following criteria:\n\n1. Be unrelated to an affected participant\n2. Be unaffected by food allergy (as determined by clinical history and\u002For allergy testing) or be unaffected by the genetic condition under study\n\nADDITIONAL PROCEDURE- SPECIFIC INCLUSION CRITERIA:\n\nThe following additional inclusion criteria apply for participants undergoing leukapheresis:\n\n1. Age \\>= 18 years\n2. Stable hematologic parameters (definition: white blood cell count \\> 2,500\u002FmicroL, hemoglobin \\> 10 g\u002FdL, and platelet count \\> 75,000\u002FmicroL)\n\nGENERAL EXCLUSION CRITERIA:\n\nParticipants will be excluded for any of the following:\n\n* Presence of conditions that, in the judgment of the investigator or the referring physician, may put the participant at undue risk or make them unsuitable for participation in the study.\n* Inability to participate for the duration of the study.\n* The PI deems that participation in the study would not be expected to advance the study goals.\n\nADDITIONAL PROCEDURE- SPECIFIC EXCLUSION CRITERIA\n\nAdditional exclusion criteria apply for unaffected relatives and healthy volunteers who are undergoing endoscopy with biopsies for research purposes. Unaffected relatives and healthy volunteers will be excluded from participating in this procedure if they meet any of the following criteria:\n\n1. uncontrolled asthma or Grade 3 or higher by the American Society of Anesthesiologist s Physical Status Classification System (https:\u002F\u002Fjournals.lww.com\u002Fanesthesiologyopen\u002Ffulltext\u002F2026\u002F04000\u002Famerican\\_society\\_of\\_anesthesiologists\\_statement\\_on.2.aspx)\n2. history of adverse reaction to conscious sedation or general anesthesia required for endoscopy\n3. hemoglobin \\\u003C 11 g\u002FdL\n4. platelet count \\\u003C 100,000 microL\n5. PT INR \\>1.3 or PTT prolonged by \\> 3 seconds\n6. pregnant or breastfeeding\n7. viral screens positive for HIV or hepatitis B or C\n8. severe unstable myocardial ischemia or cardiomyopathy\n9. severe hypoxemia due to chronic pulmonary disease\n10. recent abdominal surgery\n11. anticoagulant therapy that cannot be interrupted\n12. history of reflux disease within the last 3 years or use of acid-suppression medication (including over-the-counter medications such as Tums, Rolaids, Zantac, Prilosec OTC, or Prevacid OTC) within the last 2 months\n13. chronic GI or immunologic disease\n14. clinically indicated EGD or colonoscopy within the past 12 months\n15. use of systemic or inhaled corticosteroids within the past 4 months\n16. have a history of EGID including EoE\n17. younger than 18 years of age",true,"ALL","1 Day","99 Years",{"count":21,"type":22},1800,"ESTIMATED","OBSERVATIONAL","Background:\n\n\\- About 15 million Americans have a food allergy. Because there are no cures or effective prevention or treatment for food allergies, researchers want to learn more about them.\n\nObjective:\n\n\\- To learn more about the causes and effects of food allergy and related conditions.\n\nEligibility:\n\n* People ages 2 99 who have food allergy and\u002For a related genetic or other condition\n* Their relatives\n* Healthy relatives and volunteers\n\nDesign:\n\n* Participants will have at least 3 visits over 1 2 years, and then once a year for up to 12 years. Each may last a day or longer.\n* Participants will be screened with medical history, physical exam, and questionnaires.\n* Participants may have the following:\n* Blood tests\n* Allergy skin prick tests: Drops of allergens are placed on the back or arm. The skin is scratched under each drop.\n* Leukapheresis: blood is taken from a needle in one arm, passed through a machine, and returned through a needle in the other arm.\n* X-rays\n* Esophageal string test: One end of a string is taped to the cheek and the other end is packed into a capsule. When the capsule is swallowed, the string unwinds; it is left in for at least 1 hour.\n* EGD and colonoscopy: Biopsies are taken from the gastrointestinal system.\n* Tiny biopsies of skin\n* Photographs of the body\n* Collection of cells through:\n* Swab of nose, inside of cheek, or skin\n* Gentle skin scrape\n* Tape stripping: piece of tape is put on the skin and pulled off.",[26,27,28,29],"Food Allergy","Loeys-Dietz Syndrome","Atopic Dermatitis","Eosinophilic Esophagitis",[29,27,28,31,32],"TGFbeta","Natural History","RECRUITING","2026-06-30",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":37},"2015-07-29",{"date":41,"type":22},"2027-06-15",{"name":43,"class":44},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":16,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":66,"leadSponsor":68,"locationsCount":45},"100617661","early-introduction-and-sustained-ingestion-eisi-using-two-educational-opportunities-in-infants-100617661","NCT07321522","Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities in Infants","Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities - A Pilot Study","Inclusion Criteria for both Infant and Caregiver\u002FParent Participants\n\n* Born term (37 weeks - 41 weeks gestation)\n* Infants with or without a family history of allergic disease\n* Infants with or without mild to moderate eczema\n* Infants who have not yet started consuming known allergenic foods (excluding cow's milk or soy if it is in their infant formula)\n* Parent or caregiver ≥ 18 years of age\n* Agree to infant blood draw (two)\n* Agree to participate in the 6 month research study\n\nExclusion Criteria:\n\n* Infants with a physician confirmed food allergy\n* Infants who do not eat fully by an oral route such as tube-fed or tube-supplemented babies\n* Infants with developmental delay\n* Infants with severe eczema\n* Infants who are already consuming known allergenic foods\n* Infants participating in another study looking at diet, oral immunotherapy or the use of a biological agent","4 Months","11 Months",{"count":56,"type":22},92,"INTERVENTIONAL",[59],"NA","The objective of the study is to see whether early feeding of potentially allergic foods can be increased with educational materials alone or with educational materials and additional in-person support opportunities. This study will help guide what types of support pediatricians and allergists give to new parents.",[26],"2026-06-23",{"date":64,"type":37},"2026-06-26",{"date":34,"type":22},{"date":67,"type":22},"2028-02",{"name":69,"class":70},"Stanford University","OTHER",{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":83,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":84,"locationsCount":4},"100564630","expanded-access-of-dupilumab-in-adults-with-severe-immunoglobulin-e-ige-mediated-food-allergy-previously-treated-with-linvoseltamab-100564630","NCT06631677","Expanded Access of Dupilumab in Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy Previously Treated With Linvoseltamab","An Open Label, Expanded Access Program of Dupilumab in Adults With Severe IgE-Mediated Food Allergy Who Have Been Previously Treated With Linvoseltamab and Background Dupilumab","Key Inclusion Criteria\n\n1. Eligible participants for this program consist of adults who have completed the End of Study (EOS) visit in the parent phase 1 study, R5458-668-ALG-2219 (NCT06369467)\n2. Administration of first dose of EAP dupilumab occurs as defined in the protocol\n\nKey Exclusion Criteria\n\n1. Participants who, during the parent study (R5458-668-ALG-2219 \\[NCT06369467\\]), developed a Serious Adverse Event (SAE) and\u002For Adverse Event (AE) as defined in the protocol\n2. Any temporary discontinuation of study drug dupilumab lasting \\>2 weeks during the parent study R5458-668-ALG-2219 (NCT06369467)\n3. Greater than 2 weeks since last administration of study drug dupilumab from the parent study R5458-668-ALG-2219 (NCT06369467)\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply.","18 Years","EXPANDED_ACCESS","This is an expanded access program of dupilumab. The objective of the program is to provide continued dupilumab to adult participants with severe IgE-mediated food allergy who were previously treated with a short course of linvoseltamab and background dupilumab in the parent study R5458-668-ALG-2219 (NCT06369467).",[26],"AVAILABLE",{"date":64,"type":37},{"name":85,"class":86},"Regeneron Pharmaceuticals","INDUSTRY",{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":16,"sex":17,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":57,"phases":98,"briefSummary":99,"conditions":100,"keywords":105,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":45},"100609281","emotichealth-promoting-adolescent-health-through-a-serious-game-100609281","NCT07212530","EmoTIChealth: Promoting Adolescent Health Through a Serious Game.","\"Promoting Health in Adolescents With and Without Chronic Diseases Through Emotional Development: Design and Implementation of a Serious Game Technology Platform (EmoTIChealth)\"","Inclusion Criteria:\n\n* Informed consent by parents\u002Fguardians and participants.\n* Aged between 12 and 16 years old\n\nExclusion Criteria:\n\n* No access to internet or new technologies\n* Not a Spanish speaker.","12 Years","16 Years",{"count":97,"type":22},600,[59],"The intervention program targets adolescents between 12 and 16 years of age. The intervention program is designed for adolescents during a critical developmental stage marked by significant life transitions, where building strong personal resources and receiving psychological support is essential to foster socioemotional skills and overall well-being. The serious game aims to promote psycho-emotional health in the general adolescent population, supporting healthy development and preventing future emotional difficulties. At the same time, it incorporates specific modules for adolescents living with chronic conditions such as asthma, food allergy, type 1 diabetes, and allergic rhinitis, who may face additional risks of psychological challenges that can complicate treatment and prognosis. By combining universal health promotion with tailored support, the program addresses both the needs of healthy adolescents and those with chronic illnesses.\n\nThe platform integrates digital and technological tools for dynamic and personalized intervention. Artificial intelligence adapts activities and feedback to each participant's socio-demographic profile and evolving needs, this supports directly in participants' daily lives and natural environments, making the experience more relevant and impactful. The serious game, proven effective in engaging young people, goes beyond traditional psychoeducation by creating an interactive environment where adolescents develop socio-emotional competencies, resilience, and health-related knowledge. Through its six thematic areas, the game promotes overall well-being and healthy habits, while its condition-specific modules provide targeted guidance and coping strategies for asthma, food allergies, type 1 diabetes, and allergic rhinitis.",[101,102,103,26,104],"Type 1 Diabetes","Asthma","Allergic Rhinitis","Adolescent Development",[101,102,103,106,107,108,109,110,111,112,113,114],"Food allergy","Serious Game","Technology platform","Psychological intervention","Adolescence","Quality of life","chronic organic illnesses","Socioemotional Education","Health Promotion","2026-05-12",{"date":117,"type":37},"2026-05-13",{"date":119,"type":37},"2025-12-01",{"date":121,"type":22},"2027-08-30",{"name":123,"class":70},"University of Valencia",{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":17,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":57,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"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.","2 Years","17 Years",{"count":134,"type":22},75,[136],"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.",[139,26],"Food Allergy in Children",[141,142,143,144],"food allergy","cashew allergy","tree nuts","oral immunotherapy",{"date":146,"type":37},"2026-05-15",{"date":148,"type":37},"2024-06-01",{"date":150,"type":22},"2028-06-30",{"name":152,"class":70},"Chinese University of Hong Kong",{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":160,"maxAge":78,"enrollmentInfo":161,"targetDuration":4,"studyType":57,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100545343","stepwise-heat-denaturated-protein-introduction-for-tolerance-induction-in-food-allergy-100545343","NCT06380673","Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy","TEHITI","Inclusion Criteria:\n\n* Children (1-18y) had or have a clinical diagnosis of IgE mediated cow's milk allergy based on positive history as well as skin prick testing and\u002For specific IgE detection by CAPtest in an allergy clinic.\n* Children are at least 12 months old before introduction of heated cow's milk is considered.\n* Children did not suffer from grade 4 anaphylaxis due to cow's milk-ingestion at presentation.\n* Children have specific IgE levels to Bos d 8 below 1.2 kU\u002FmL and\u002For children passed 20' cooked cow's milk provocation test executed on clinical judgement.\n\nExclusion Criteria:\n\n* Children had grade 4 anaphylaxis due to cow's milk ingestion.\n* Children are younger than 12 months old at the moment of passing 20' cooked cow's milk OFC.\n* Parents are not able or not willing to adhere to a specific cow's milk protein-containing diet on a regular basis at home.\n* Multiple food allergy, not compatible with any of the choices in the Flemish Milk Ladder.\n* Parents and\u002For children are not willing to give IC\u002Fassent.","1 Year",{"count":162,"type":22},90,[59],"This interventional study aims to validate an early heated protein introduction protocol in cow's milk allergic children who already developed tolerance towards extensively heated cow's milk, in order to speed up the development of complete cow's milk tolerance. Natural complete tolerance induction towards cow's milk takes several years of strict cow's milk avoidance with high risk of anaphylaxis by accidental cow's milk intake. By shortening the time towards complete tolerance, not only the quality of life of both children and parents ameliorates drastically, the time frame for potential anaphylactic reactions is also strongly reduced and can be considered as a preventive strategy to reduce allergic reactions too. Moreover, this strategy has proved efficient for hen's egg allergy. The main question this study wants to answer is whether a 12 months stepwise heated cow's milk introduction (either by gradual reduction of the cooking time or by the use of the Flemish Milk Ladder) in 20'-cooked cow's milk tolerant subjects, results in a larger proportion of complete cow's milk tolerant children after 12 months compared to natural tolerance induction (with 20' cooked milk introduction only).",[26,166],"Cow Milk Allergy","2026-05-04",{"date":169,"type":37},"2026-05-08",{"date":171,"type":37},"2024-04-22",{"date":173,"type":22},"2029-12-30",{"name":175,"class":70},"Universitaire Ziekenhuizen KU Leuven",5,{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":16,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":57,"phases":187,"briefSummary":188,"conditions":189,"keywords":205,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":226},"100556807","environmental-exposure-to-heavy-metals-nanoparticles-and-emergent-contaminants-and-risk-of-allergic-diseases-100556807","NCT06529913","Environmental Exposure to Heavy Metals, Nanoparticles, and Emergent Contaminants and Risk of Allergic Diseases","Model of diseAses Related to Environmental Exposure to Heavy meTals, nanopaRticles and Emergent Contaminants, Using a dIgital platfOrm of Clinical and Bio-humoral Data: the Way to Susceptibility\u002FRisK BiomArker [MATRIOSKA Study] - The Seed.","MATRIOSKA","Inclusion Criteria:\n\n* adult subjects (over 18 years of age).\n* Subjects suffering from allergic contact dermatitis due to metals.\n* Subjects with systemic allergic syndrome due to metals.\n* Adult healthy subjects.\n* Subjects able to give written informed consent.\n\nExclusion Criteria:\n\n* Subjects under the age of 18years.\n* Pregnant\u002Fbreastfeeding women.\n* Subjects suffering from chronic renal failure requiring replacement treatment.\n* Subjects suffering from other systemic pathologies related to exposure to metals.\n* Subjects suffering from gastrointestinal diseases such as celiac disease, chronic inflammatory intestinal diseases, tumors, other skin diseases.\n* Subjects unable to express written informed consent.",{"count":186,"type":22},280,[59],"The goal of this clinical trial is to collect environmental, bio-humoral, and clinical data derived from patients with allergic contact dermatitis (ACD) and systemic metal allergic syndromes related to the exposure to heavy metals, nanoparticles, and emergent contaminants and from healthy subjects.\n\nThe main question it aims to answer is: are environmental, bio-humoral, and clinical data derived from patients with ACD and systemic metal allergic syndromes, related to the exposure to heavy metals, nanoparticles, and emergent contaminants, different from ones obtained by healthy subjects? Researchers will compare serum and urine concentration of heavy metals and nanoparticles, patch test to metals, within-breath analysis of oscillometry parameters, serum zonulin, and serum levels of protein oxidation products among patients with systemic allergic syndrome (1st study group), patients with ACD (2nd study group) and healthy subjects (3rd study group).\n\nParticipants will undergo:\n\n* measurement of exposure to heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper, through serum and urine measurement of concentration.\n* Patch test to before mentioned metals.\n* Within-breath analysis of oscillometry parameters.\n* Measurement of serum zonulin (related to gastro-intestinal exposure).\n* Measurement of serum levels of protein oxidation products (as markers of systemic oxidative stress).",[190,191,26,192,193,194,195,196,197,198,199,200,201,202,203,204],"Allergic Contact Dermatitis","Metal Allergy","Nickel Sensitivity","Nickel; Eczema","Aluminum Allergy","Chromium; Eczema","Functional Gastrointestinal Disorders","Respiratory Injury","Pollution; Exposure","Pollution Related Respiratory Disorder","Environmental Exposure","Environment Related Disease","Environmental Illness","Oxidative Stress","Risk Reduction",[191,206,207,208,209,210,211,212,213,214,190,26,196,197,200,215,216],"Nanoparticles","Emergent contaminants","Nickel","Aluminium","Copper","Chromium","Cobalt","Palladium","Titanium","Patch test","Biomarkers","2026-02-23",{"date":219,"type":37},"2026-02-24",{"date":221,"type":37},"2025-01-13",{"date":223,"type":22},"2026-12-31",{"name":225,"class":70},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",2,{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":17,"minAge":160,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":57,"phases":237,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":252},"100588602","phase-2-omalizumab-weight-based-dosing-efficacy-trial-100588602","NCT06943534","Omalizumab Weight-Based Dosing Efficacy Trial","OWED-T","Inclusion Criteria:\n\n* A positive prick skin test (PST) with a wheal ≥ 6 mm to at least two of the relevant foods (peanut, cashew, walnut, egg, or milk)\n* Positive food specific IgE (≥2.0 kUA\u002FL) to at least two of the relevant foods\n* A positive history of clinical reaction to at least one of the qualifying foods other than the challenge-qualifying food\n\n(If meeting above criteria):\n\n* Positive oral food challenge (OFC) to one of the potentially qualifying foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg)\n\nExclusion Criteria:\n\n* Weight \\>80 kg at time of screening\n* Clinically significant laboratory abnormalities at screening.\n* Sensitivity or suspected\u002Fknown allergy to any ingredients (including excipients) of omalizumab.\n* Poorly controlled or severe asthma\u002Fwheezing at screening\n* History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise, PICU admission f for continuous epinephrine for hypotension or severe respiratory compromise requiring intubation.\n* Treatment with a burst of 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.\n* Past or current history of eosinophilic gastrointestinal disease within three years of screening.\n* Past or current history of cancer, or currently being investigated for possible cancer.\n* Past or current history of any food immunotherapy (e.g., OIT, SLIT, EPIT) within 6 months of screening.\n* Treatment with monoclonal antibody therapy, or other immunomodulatory therapy within 6 months of screening.\n* Inability to discontinue antihistamines for minimum wash-out periods required for SPTs or OFCs.\n* Pregnant or breastfeeding or intending to become pregnant during the study.\n* Evidence of clinically significant chronic disease.","55 Years",{"count":236,"type":22},30,[136],"This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.",[240,26],"Allergies",[242],"omalizumab","2026-02-03",{"date":245,"type":37},"2026-02-05",{"date":247,"type":37},"2025-07-03",{"date":249,"type":22},"2028-04-01",{"name":251,"class":70},"Massachusetts General Hospital",3,{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":57,"phases":262,"briefSummary":263,"conditions":264,"keywords":265,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":45},"100583182","trophallergen-prick-tests-pt--influence-of-food-sample-shelf-life-on-the-reproducibility-of-pt-results-100583182","NCT06872996","Trophallergen Prick Tests (PT) : Influence of Food Sample Shelf Life on the Reproducibility of PT Results","TROPHAPRICK","Inclusion Criteria:\n\n1. Aged 18 and over.\n2. Having a diagnosis of food allergy(ies) due to one or more of the food allergen studied, previously made by an allergologist, of grade 2 to 3 according to the Ring and Messmer classification.\n3. Having given consent to participate in the study.\n\nThe diagnosis is made by the allergologist of the department due to the presence of a compatible clinical history implicating the tested allergen, the presence of evidence of sensitization to the allergen (positive prick-test and\u002For positive specific IgE assays), or even a positive oral allergen reintroduction test.\n\nExclusion Criteria:\n\n1. Anaphylactic reaction dating less than 6 weeks\n2. Hospitalization for asthma in the past 3 months\n3. History of grade 4 anaphylactic reaction according to the Ring and Messmer classification.\n4. Systemic antihistamine treatment in the 7 days preceding the test\n5. Systemic beta-blocker treatment on the day of the test.\n6. Protected person (under guardianship or curatorship)\n7. Person under judicial supervision\n8. Persons deprived of liberty\n9. Person not affiliated with a social security insurance\n10. Pregnant or breastfeeding women",{"count":261,"type":22},100,[59],"Prick tests (PT) are the standard skin tests used in the investigation of immediate IgE-mediated food allergies. Their use as a first-line tool in allergological investigations is strongly recommended by the European Academy of Allergy and Clinical Immunology (EAACI). These tests involve locally reproducing histamine release manifestations in the epidermis by superficially introducing an allergen to confirm or rule out its role in the onset of clinical symptoms compatible with an allergy. During the diagnostic management and follow-up of patients with food allergies, the technique used is the \"prick to prick\" method, due to the lack of reliable access to many standardized commercial food extracts. This method involves piercing the food with a sterile lancet (to deposit food content on its surface) and then making a superficial skin puncture with the same device on the anterior surface of the forearm to introduce a tiny fraction of the food and its proteins into the epidermis, where mast cells are present. Simultaneously, a positive control and a negative control are performed. The tests are read after 15 to 20 minutes by measuring the size in millimeters of the resulting papules and erythema. A PT for the tested allergen is considered positive if the average diameter of the resulting papule is 3 mm or more and\u002For at least half the size of the positive control papule. The procedure is well-tolerated, allowing it to be performed at any age, in both hospital and outpatient settings. The risk of a systemic reaction has been evaluated at 0.008%, with no severe reactions observed.\n\nThis method, performed with native foods (unprocessed food, uncontaminated foods), either raw or cooked (depending on the nature of the allergen being tested), is preferred over the use of commercial extracts (standardized commercial allergen preparations) due to its better sensitivity and specificity, the high cost of commercial extracts, and the lack of commercial extracts for certain foods. For practical reasons, given the wide variety of possible allergens, and to most accurately reproduce the exposure that caused the reaction, the most common approach is to ask the patient to bring their own foods for testing. These foods should be brought in a fresh state. However, situations where the patient is offered a food PT but does not have fresh native foods are common. Indeed, many patients forget to bring them. Similarly, during a consultation to explore a respiratory or drug allergy, the interview may lead to the detection of a food allergy that needs to be tested at the same time. Given the delays in allergology consultations, the severity of food allergy symptoms, and the potential risk of delayed diagnosis, all allergists involved in managing food allergies are led to create a library of food samples stored either in a dry state (e.g., nuts, peanuts, cereal flours) or frozen for perishable foods (meats, shellfish, fruits, vegetables). To our knowledge, after reviewing the literature, no guidelines for best practices regarding the storage of these food samples for PT purposes have been established by scientific societies. Moreover, while the impact of freezing and thawing methods on the denaturation of food proteins is known, the effect of freezing and its duration on the sensitivity and specificity of PT is poorly understood.\n\nThe objective of our study is to evaluate the reproducibility of PT results between those performed with fresh foods and those performed with preserved foods at different storage dates in participants who have experienced anaphylaxis of at least grade 2 according to the Ring and Messmer classification.",[26],[266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281],"Prick test","Skin test","Trophallergen","Food sample","Fresh","Frozen","Fruit","vegetables","Meat","Alpha-gal","Arachide","Leguminous plant","Milk","Nuts","Fish","Seafood","2025-12-22",{"date":284,"type":37},"2025-12-30",{"date":286,"type":37},"2025-04-10",{"date":288,"type":22},"2027-10-10",{"name":290,"class":70},"Centre Hospitalier Régional d'Orléans",{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":17,"minAge":298,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":45},"100327177","prescreening-protocol-to-enroll-in-food-allergy-clinical-studies-at-a-single-site-100327177","NCT03539692","Prescreening Protocol to Enroll in Food Allergy Clinical Studies at a Single Site","Prescreen","Inclusion Criteria:\n\n* Any individual with possible food allergy (as per their clinical history) who is interested in performing the gold standard food challenge for diagnosis.\n\nExclusion Criteria:\n\n* Any individual who does not consent\n* Any individual who is currently taking oral steroids\n* Any individual with moderate to severe asthma (FEV1\\\u003C80%)","1 Week","90 Years",{"count":301,"type":22},1000,"This is a protocol for prescreening of participants who would like to be in clinical studies in our Center at Stanford.",[26],"2025-11-25",{"date":306,"type":37},"2025-12-02",{"date":308,"type":37},"2018-06-10",{"date":310,"type":22},"2028-12",{"name":69,"class":70},{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":16,"sex":17,"minAge":318,"maxAge":234,"enrollmentInfo":319,"targetDuration":4,"studyType":57,"phases":321,"briefSummary":322,"conditions":323,"keywords":325,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":45},"100539196","michigan-food-and-atopic-dermatitis-m-fad-program---molecular-analytics-project-100539196","NCT06300697","Michigan Food and Atopic Dermatitis (M-FAD) Program - Molecular Analytics Project","Food allergy-only group Inclusion Criteria:\n\n* Have a known history of food anaphylaxis to peanut, tree nut, egg, milk, or sesame confirmed by an allergist.\n* Have had skin and blood food allergy testing to the food allergen in question within the past 6 months. Meet the 80% likelihood positive predictive value threshold for allergy based on at least 1 of either the skin or blood immunoglobulin E (IgE) tests per current literature corrected for age. See protocol for more details.\n* No history of atopic dermatitis\n\nFood allergy plus atopic dermatitis group Inclusion Criteria:\n\n\\- Meet the \"food allergy only group\" inclusion criteria except this group must also have atopic dermatitis.\n\nAtopic dermatitis without food allergy Inclusion Criteria:\n\n* Have a present diagnosis of atopic dermatitis by an allergist and\u002For dermatologist.\n* Have no history of food allergy, past or present.\n\nControl Group Inclusion Criteria:\n\n\\- No history of food allergy or atopic dermatitis, past or present.\n\nExclusion Criteria for all groups:\n\n* People younger than age 10 or older than age 55\n* Any active cardiovascular disease, cancer, pulmonary disease except well-controlled asthma, or other condition that would preclude an OFC otherwise. Mild conditions that would not preclude an OFC are allowed (i.e., controlled hypertension or a surgically removed skin cancer that is resolved would not be exclusionary for this study, for example).\n* Any medication use that cannot be stopped temporarily for the OFC that would interfere with the OFC result. Medications in this category include antihistamines (first or second generation) within 1 week.\n* Any skin condition aside from atopic dermatitis per inclusion criteria groups that might impact the study, including such conditions as autoimmune skin conditions (such as psoriasis), congenital ichthyoses, hyper-IgE syndromes.\n* Any recent change (within 6 months) of starting or stopping a biologic medication, such as dupilumab, tezepelumab, or others that might interfere with atopic dermatitis or food allergy.\n* Any past or present history of oral immunotherapy (OIT) for any food allergen.\n* Pregnancy - females of childbearing age will be asked and self-report pregnancy status.","10 Years",{"count":320,"type":22},200,[59],"This study will explore potential links between atopic dermatitis and food allergy. This information will be useful to determine atopic dermatitis and food allergy share unique biochemical or genetic identifiers useful for diagnosing and treatments in the future.\n\nThis is a mechanistic study consisting of obtaining blood and skin samples from participants at baseline. Individuals may also undergo a clinically indicated oral food challenge and have blood and skin samples collected at various times during the oral food challenge. This study will create a molecular map of the pathology of atopic dermatitis and food allergy. This information will be deployed to evaluate the hypothesis that atopic dermatitis and food allergy share unique genetic transcriptional signals in which the study team can then further analyze pathological pathways and cell types.",[28,26,324],"Healthy",[326,327,328,329],"Blood Samples","Skin Samples","Transepidermal water loss (TEWL) monitor","Allergic reaction","2025-11-19",{"date":304,"type":37},{"date":333,"type":37},"2024-02-15",{"date":335,"type":22},"2027-03",{"name":337,"class":70},"University of Michigan",{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":17,"minAge":346,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":57,"phases":349,"briefSummary":350,"conditions":351,"keywords":352,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":45},"100530178","analysis-of-the-prevalence-of-sensitization-to-plants-containing-gibberellins-using-realistic-skin-prick-tests-100530178","NCT06183398","Analysis of the Prevalence of Sensitization to Plants Containing Gibberellins Using Realistic Skin Prick Tests","Analysis of the Prevalence of Sensitization to Plants Containing Gibberellins Using Realistic Skin Prick Tests in a Population of Patients Attending the Montpellier University Hospital.","GIBBERELLINES","Inclusion Criteria:\n\n* Patients aged at least 5 years\n* Patients consulting at the Allergy Unit of the University Hospital of Montpellier for any type of allergy work-up\u002Fevaluation\n* Oral consent from the patient and, where applicable, from at least one of the patient's legal representatives in the case of minors.\n\nExclusion Criteria:\n\n* Patients treated with antihistamines or psychotropic drugs with antihistaminic action during the 7 days prior to inclusion\n* Patients with pathologies that prevent the performance of prick tests (e.g. severe peripheral neuropathy, cutaneous anergy).\n* Patients with dermographism.\n* Patient taking part in another study which may influence the results of the prick tests.\n* Patients in an exclusion period determined by a previous study.\n* Pregnant, parturient or breast-feeding women.\n* Patients or their legal representatives under court protection, guardianship or trusteeship.\n* Patients or their legal representatives who are not members or beneficiaries of a health insurance scheme.\n* Patient or his\u002Fher legal representative unable to read and understand French fluently.","5 Years",{"count":348,"type":22},2000,[59],"Gibberellin-related proteins (GRPs) are proteins contained in both pollens and vegetables and are associated with an increased risk of severe food allergy reactions. The best characterized one the only one for which a specific IgE (Immunoglobulin E) may be dosed in current clinical practice is Pru p 7, an allergen contained in peaches (Prunus persica). Sensitization to GRPs seems to be greater in areas with high exposure to pollens of the Cupressaceae family (as in the Montpellier region in Southern France); a subtype of Cupressaceae pollinosis, characterized by sensitization to Pru p 7 has been shown to be responsible for severe peach allergies.\n\nTo date, there has been no real analysis of the prevalence of sensitization to GRPs, or of possible cross-sensitization between plants and foods containing GRPs. Main food containing GRPs with a high level of homology with Pru p 7 include apples (Malus domestica, 97.3%), sesame (Sesamum indicum, 91.9%), carrots (Daucus carota subsp. Sativus, 88.9%), lemons and oranges (different species, with a homology of 87.3%).\n\nIf investigators consider that sensitization to GRPs could be associated with severe allergic hypersensitivity reactions, it is important to detect the prevalence of sensitization to these allergens and to find sensitization profiles for these patients in order to gain a better understanding of this type of allergy and offer a more appropriate and preventive management to allergic patients. This remains today a major challenge for the allergy community in the Mediterranean region.\n\nThis study aims to investigate the rate of sensitization to peach and 5 other allergens containing gibberellins, chosen on the basis of their homology with Pru p 7 (the gibberellin from Prunus persica): carrot, lemon, orange, apple and sesame.",[26],[353,354,355,356,357],"Gibberellins","prevalence","sensitization","Pru p 7","cross-reactions","2025-09-29",{"date":360,"type":37},"2025-10-03",{"date":362,"type":37},"2024-03-14",{"date":364,"type":22},"2028-03-14",{"name":366,"class":70},"University Hospital, Montpellier",{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":376,"conditions":377,"keywords":379,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":45},"100077766","data-and-sample-collection-study-to-elucidate-the-mechanisms-of-eosinophilic-disorders-100077766","NCT00267501","Data and Sample Collection Study to Elucidate the Mechanisms of Eosinophilic Disorders","Eosinophils and Inflammation, an Expanded Study","Inclusion Criteria:\n\n* Signed informed consent obtained from the patient or parent\u002Fguardian. Assent will be obtained from all minors 11 years of age and older.\n* Carrying a diagnosis of eosinophilic gastrointestinal disease, eosinophilic inflammatory disease, or food allergy OR family member, or normal control",{"count":375,"type":22},5000,"The purpose of this study is to elucidate the mechanisms underlying eosinophil growth, survival, migration, and function and to investigate and further characterize the pathophysiology of, clinical manifestations of, and spectrum of disease severity of eosinophilic inflammation in humans.",[378,26],"Eosinophilic Gastrointestinal Disease Eosinophilic Inflammatory Disease",[380],"Eosinophilic Disorders","2025-09-11",{"date":383,"type":37},"2025-09-17",{"date":385,"type":4},"2005-05",{"date":387,"type":22},"2050-01",{"name":389,"class":70},"Children's Hospital Medical Center, Cincinnati",{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":17,"minAge":398,"maxAge":399,"enrollmentInfo":400,"targetDuration":4,"studyType":57,"phases":402,"briefSummary":403,"conditions":404,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":45},"100557080","randomized-controlled-trial-of-slow-multiallergen-oral-immunotherapy-in-young-children-100557080","NCT06533462","Randomized Controlled Trial of Slow Multiallergen Oral Immunotherapy in Young Children","Infant Food Allergen Oral Immunotherapy (InFO)","InFO","Inclusion Criteria:\n\n* 0.5-3 years old at inclusion with IgE (\\>0.1 kUA\u002Fl) against at least one allergen (wheat, lentils, egg, milk, soy, walnut, hazelnut, peanut, almond, cashew).\n* Written consent for participation in the study for both guardians.\n* 80 children (group A and B) also need a positive baseline food challenge.\n* Children with a negative food challenge (group C and D) (number not determined) do not react at the baseline challenge.\n\nExclusion Criteria:\n\n* other serious illness\n* previous life-threatening anaphylaxis (intensive care)\n* eosinophilic esophagitis\n* eosinophilic gastrointestinal disease\n* severe chronic gastroesophageal reflux disease\n* unclear recurrent GI complaints\n* low body weight \\\u003C2SD\n* participation in another intervention study if included in intervention group\n* severe uncontrolled asthma\n* medication with biological drugs or oral steroids.","6 Months","3 Years",{"count":401,"type":22},80,[59],"The aim is to study whether a multiallergen oral immunotherapy (OIT) strategy with slow up-dosing and low treatment dose against food allergy in young children (0.5-3 years) is safe and effective, a method to cure food allergy and to prevent the development of new food allergies.\n\nClinical randomized controlled (1:1) blinded interventional trial (RCT) with 2 intervention arms (group A and B).\n\nAmong 80 children reacting at the multiallergen food challenge, 40 children will be randomized to receive OIT (oral immunotherapy) with multiallergen powder with a final dose of approximately 200 mg protein of each included food (egg, milk, soy, wheat, walnut, peanut, hazelnut, cashew, almond, lentils)(group A) or to receive placebo powder (gluten-free oatmeal) (group B).\n\nA sub-analysis will be performed of the children not reacting to the baseline challenge, who will be randomized to eat a low dose of the multiallergen powder (group C) or placebo powder (gluten-free oatmeal) (group D) and no specific advice.",[26,405],"Oral Immunotherapy for Food Allergy","2025-09-09",{"date":408,"type":37},"2025-09-16",{"date":410,"type":37},"2024-11-08",{"date":412,"type":22},"2027-12",{"name":414,"class":70},"Karolinska Institutet",{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":17,"minAge":94,"maxAge":132,"enrollmentInfo":422,"targetDuration":4,"studyType":57,"phases":424,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":45},"100492677","phase-2-evaluating-the-safety-and-efficacy-of-oral-encapsulated-microbiota-transplantation-therapy-in-peanut-allergic-patients-100492677","NCT05695261","Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients","A Phase II Trial to Evaluate the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients","The study will enroll 24 peanut allergic patients aged 12-17 who meet the eligibility criteria in Part A and 13 subjects aged 12-17 years who meet eligibility criteria in Part B.\n\nInclusion Criteria:\n\nMale and female young adults aged 12-17 years, who meet all the following inclusion criteria, will be enrolled in the study.\n\n1. Develop dose limiting symptoms to peanut during a DPBCFC conducted in accordance with PRACTALL (Practical Issues in Allergology, Joint United States\u002FEuropean Union Initiative) guidelines at 1 mg, 3 mg, 10 mg, 30 mg, or 100 mg peanut protein (Part A only).\n2. Has a positive SPT to peanut (≥3mm) and\u002For a positive peanut-specific IgE \\>0.35kU\u002FL (Part A only).\n3. For asthmatic patients, has a Spirometry or Peak Flow with Measurement of FEV1\\>=80% of predicted\n4. Has a negative urine hCG test if a female participant.\n5. Agrees to use an acceptable single-barrier form of birth control from enrollment through the exit DBPCFC study visit if female of childbearing potential and sexually active. An example of a single-barrier method of contraception includes condoms or oral contraceptives. Acceptable methods of birth control include implants, injectables, combined oral contraceptives, some intrauterine contraceptive devises (IUDs), sexual abstinence, a vasectomized partner, the contraceptive patch, the contraceptive ring, and condoms.\n6. Able to swallow 2 empty capsules size 00.\n7. Able to give informed assent and guardian willing to give informed consent.\n8. Willing and able to participate in the study requirements, including study visits, food challenges, serial stool collection\n9. Willing to undergo telephone or email follow-up to assess for safety and adverse events.\n10. Subject has been on maintenance peanut oral immunotherapy for at least a year (part B only).\n\nExclusion Criteria:\n\nSubjects who fall into any of the following exclusion criteria at the time of screening are not eligible for enrollment into the study.\n\n1. Patients with a history of severe anaphylaxis to any food (hypotension requiring vasopressor support, hypoxia requiring mechanical ventilation, or neurological compromise)\n2. For Part A, patients with current diagnosis of an IgE mediated reactions to food (excluding allergic reactions to peanut, tree nuts, egg and milk, provided that MTT does not contain traces of these food estimated to be above the LOAEL in 5 capsules combined, and excluding oral allergy syndrome, and excluding other foods that the MTT donor avoided)\n3. For Part B, patients with current diagnosis of an IgE mediated reactions to food (excluding allergic reactions to peanut, tree nuts, egg and milk, provided that MTT does not contain traces of tree nuts, egg and milk estimated to be above the LOAEL in 4 capsules, and excluding oral allergy syndrome, excluding the food that the patient is undergoing immunotherapy to, and excluding other foods that the MTT donor avoided).\n4. Patients with chronic illness other than controlled asthma that is mild intermittent, mild- persistent or moderate persistent, mild eczema and allergic rhinitis. Exceptions can be made per PI discretion if illness is not expected to affect allergies or treatment.\n5. Recurrent or chronic infections necessitating frequent systemic (including oral) antibiotic administration.\n6. Patients on chronic systemic immunosuppressive therapies.\n7. Patients who are diagnosed with active, chronic urticaria.\n8. Patients who have received peanut oral immunotherapy within the past 6 months (Part A only).\n9. Patients who are on the up-dosing phase of aeroallergen immunotherapy or patients who have received Omalizumab or dupilumab therapy within the past 6 months.\n10. Women who are pregnant or breast feeding or planning to get pregnant during the time of the study.\n11. Sexually active female patients who refuse to use contraception from enrollment through the third DBPCFC study visit\n12. Patient with GI conditions including inflammatory bowel disease, eosinophilic esophagitis, food protein induced enterocolitis, uncontrolled reflux despite medication, uncontrolled chronic constipation despite medication, esophageal dysmotility, swallowing dysfunction, delayed gastric emptying syndromes, pill esophagitis or history of aspiration pneumonia within 3 months prior to screening.\n13. Patient with current rheumatologic conditions. Exceptions can be made per PI discretion if illness is not expected to affect allergies or treatment.\n14. Patients with neutropenia \\\u003C1000 cells\u002FuL\n15. Patients participating or planning to participate in the next 6 months in interventional research trials. Exceptions can be made per PI discretion.\n16. Patients who have received systemic corticosteroids therapy for 1 week or more over the past 60 days.\n17. Patient with an allergy to Vancomycin or Neomycin or any component to the capsules.",{"count":423,"type":22},37,[136],"This is a phase II trial that aims at evaluating the safety and tolerability of oral encapsulated fecal microbial transplantation therapy (MTT) in peanut allergic patients. In this research the investigators would like to learn more about ways to treat peanut allergies. The primary objective for Part A is to evaluate whether MTT with antibiotic pretreatment can increase the threshold of peanut reactivity during a double-blind placebo-controlled food challenge from \\\u003C=100 mg peanut protein to 300 mg after 28 days of MTT \u002Fplacebo therapy and 4 months post therapy initiation. The primary objective for Part B is to evaluate whether MTT with antibiotic pretreatment can lead to sustained unresponsiveness (SU) defined as tolerating the same dose of peanut protein administered during a food challenge at baseline and 12 weeks after OIT cessation.",[427,428,429,430,26,431],"Allergy, Peanut","Peanut Allergy","Peanut Hypersensitivity","Peanut-Induced Anaphylaxis","Food Allergy Peanut","2025-08-19",{"date":434,"type":37},"2025-08-24",{"date":436,"type":37},"2023-06-08",{"date":438,"type":22},"2027-03-01",{"name":440,"class":70},"Rima Rachid",{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":447,"eligibilityCriteria":448,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":449,"enrollmentInfo":450,"targetDuration":4,"studyType":57,"phases":451,"briefSummary":452,"conditions":453,"keywords":4,"overallStatus":455,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":45},"100566247","early-supplementation-for-cows-milk-allergy-prevention-100566247","NCT06652698","Early Supplementation for Cow's Milk Allergy Prevention","Early Supplementation for Cow's Milk Allergy Prevention in Breastfed Infants in Poland (ESCAPE-PL): a Protocol for Randomised Controlled Trial","ESCAPE-PL","Inclusion criteria:\n\n1. Healthy newborns of mothers who express the intention to exclusively breastfeed for first 6 months of infant's life\n2. Full-term infants (defined as gestational age of at least 37 weeks)\n3. Infant birth weight at least 2500 g and ≤ 4500 g\n4. Age at enrolment \\\u003C24 h of life\n5. Regardless of any atopic condition in parents\n6. Written informed consent of the caregiver\n\nExclusion criteria:\n\n1. Infants of parents who intend to partially or fully formula feed\n2. Serious congenital anomalies or any other medical condition that would preclude the consumption of any of the study formulas, or interfere with nutrition or growth\n3. Contradictions to exclusive breastfeeding\n4. Multiple pregnancy","24 Hours",{"count":301,"type":22},[59],"Cow's milk allergy (CMA) is a common food allergy in infants and young children that can have a significant impact on the individual and their family due to dietary restrictions, risk of nutritional deficiencies, social limitations, and decreased quality of life. It also represents a financial burden for families and healthcare resources.\n\nThere is an ongoing debate about the significance of early exposure to cow's milk proteins within hours or days after birth and its relationship to the risk of developing CMA later in life. Current recommendations for early introduction of cow's milk proteins in infants who cannot be breastfed vary and are inconsistent due to a lack of clear evidence. This knowledge gap underscores the need for further research to provide a definitive understanding of the relationship between early exposure to cow's milk proteins and the development of CMA, which will ultimately inform evidence-based prevention strategies to improve the health and well-being of affected individuals and their families.\n\nThis trial aims to investigate whether early supplementation with various nutritional interventions (cow's milk formula \\[CMF\\], amino acids formula \\[AAF\\], donor human milk \\[DHM\\], or high-pressure processed \"pascalized\" donor human milk \\[DHM-P\\]) could serve as an effective strategy for the primary prevention of CMA in breastfed neonates.\n\nThis study is an open-label randomized, controlled, head-to-head trial with four parallel arms and allocation 1:1:1:1.",[26,454],"Cow's Milk Allergy","NOT_YET_RECRUITING","2025-07-14",{"date":458,"type":37},"2025-07-17",{"date":460,"type":22},"2025-07",{"date":462,"type":22},"2031-03",{"name":464,"class":70},"Medical University of Warsaw",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":17,"minAge":160,"maxAge":346,"enrollmentInfo":472,"targetDuration":4,"studyType":57,"phases":474,"briefSummary":475,"conditions":476,"keywords":479,"overallStatus":455,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":487,"leadSponsor":489,"locationsCount":226},"100596027","efficacy-and-safety-of-egg-ladders-in-children-with-ige-mediated-hens-egg-protein-allergy-100596027","NCT07040111","Efficacy and Safety of Egg Ladders in Children With IgE-Mediated Hen's Egg Protein Allergy","Efficacy and Safety of a 4-Step Versus a 5-Step Egg Ladder in Children With IgE-Mediated Hen's Egg Protein Allergy: Protocol for an Open-Label Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 12 months and ≤ 5 years.\n* Diagnosis of IgE-mediated HEA confirmed according to the EAACI guidelines by a positive OFC with hen's egg proteins. In children with high-risk HEA (e.g., history of anaphylaxis), diagnosis can be based on elevated specific IgE levels (3.5 kU\u002Fl) to hen's egg proteins and\u002For individual egg components and\u002For positive skin tests.\n* On a therapeutic elimination diet for at least 6 months, measured from the last allergic reaction to egg (in accordance with BSACI guidelines).\n* Eligible regardless of the risk of systemic reactions (e.g. anaphylaxis) or asthma.\n* Good general health.\n* Written informed consent signed by the child's guardians.\n* Demonstrated good cooperation from the patient's guardians.\n\nExclusion Criteria:\n\n* Confirmed wheat allergy and\u002For celiac disease.\n* Uncontrolled asthma, defined as the presence of shortness of breath, cough, chest tightness, or auscultatory changes despite treatment.\n* Signs of exacerbation of a chronic disease.\n* Signs of acute infectious disease (e.g. acute rhinitis, cough, subfebrile or febrile states).\n* Signs of exacerbation of another allergic disease (e.g., conjunctivitis, allergic rhinitis, atopic dermatitis).\n* Anaphylaxis due to hen's egg proteins within the last 6 months.\n* Use of antihistamines within 3-10 days before the challenge (depending on the drug and indication; time-limited contradiction - relative exclusion criterion).\n* Acquired tolerance to baked hen's egg proteins or advancement to a higher step of the egg ladder.\n* Use of immunosuppressive drugs or immunotherapy.",{"count":473,"type":22},94,[59],"Hen's Egg Allergy is one of the most common food allergies in early childhood. The first-line treatment is the elimination of hen's egg proteins from the child's or maternal diet.\n\nAvailable data from the literature indicate that most children with hen's egg allergy acquire tolerance to hen's egg proteins with age. An assessment of tolerance acquisition to them is commonly performed using egg ladder. However, scientific evidence regarding the effectiveness and safety of the egg ladder in children with hen's egg allergy is limited. Currently, there is no standardised egg ladder protocol, and different versions of the ladder and recommend by scientific societies in various countries.\n\nThis study aims to assess the effectiveness and safety of the 4-step egg ladder (4-EL) compared to the 5-step egg ladder (5-EL) in children with IgE-mediated hen's egg allergy. This is an open-label, randomised superiority trial with two parallel arms and a 1:1 allocation ratio.",[26,477,478],"Egg Allergy","Hen Egg Allergy",[480,481,482],"children","egg ladder","IgE-mediated hen egg allergy","2025-06-26",{"date":485,"type":37},"2025-07-01",{"date":460,"type":22},{"date":488,"type":22},"2028-11",{"name":464,"class":70},{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":498,"enrollmentInfo":499,"targetDuration":4,"studyType":57,"phases":501,"briefSummary":502,"conditions":503,"keywords":504,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":515,"leadSponsor":517,"locationsCount":45},"100559007","pectin-intervention-study-and-long-term-follow-up-in-lipid-transfer-proteins-allergic-patients-100559007","NCT06558526","Pectin Intervention Study and Long-term Follow-up in Lipid Transfer Proteins Allergic Patients","Analysis of the Clinical Efficacy and Immunomodulatory Effect of Pectin in LTP Allergic Patients Through a Placebo-controlled Intervention Study and Long-term Follow-up","PI23\u002F00820","Inclusion Criteria:\n\n* Adults with a clear clinical history of food allergy after eating peach (oral allergy syndrome and\u002For systemic symptoms) and with or without clinical history of food allergy with peanut.\n* Sensitization to Pru p 3 by positive skin prick test (SPT wheal area \\>7 mm2) and specific IgE (sIgE \\>0.35 kUA\u002FL)\n* Positive DBPCFC with peach juice.\n* If clinical history of food allergy with peanut, sensitization must be confirmed by positive SPT to peanut and sIgE \\>0.35 kUA\u002FL to Ara h 9 and clinical reactivity through a positive DBPCFC with peanut.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Food allergy to corn.\n* Food allergy to peanut due to sensitization to storage proteins.\n* Previous\u002Factive treatment with sublingual immunotherapy to Pru p 3.\n* Pregnancy\u002Flactation.\n* Active infections.\n* Inflammatory, autoimmune, and\u002For oncological diseases.\n* Severe immunodeficiency.\n* Metabolic syndrome.\n* Increased liver parameters and\u002For any liver disease.\n* Alcohol disorder.\n* Mental illness.\n* Mast cell activation syndrome.\n* Severe atopic dermatitis.\n* FEV1 \\\u003C 70%\n* Treatment with immunomodulators in the last five years.\n* Vitamin supplements, probiotics, prebiotics, antibiotics, metformin, statins, proton pump inhibitors, or corticosteroids in the last three months.\n* Any clinical condition contraindicating performance of DBPCFC.","60 Years",{"count":500,"type":22},62,[59],"Pectins are dietary fibers that have shown a health effect on patients with food allergy, as they are capable of modifying the composition of gastrointestinal microbiota, and producing an immunomodulatory effect. Preliminary results by the investigators show that the intervention for 2 months with pectins produces an increase in tolerance to peach, and changes in the microbiota compared to the group of patients treated with placebo. In this project, the investigators aim to study these clinical effects and the involved mechanisms. Moreover, the long-term effect (clinical reactivity to nsLTP and immunomodulatory effect) of the dietary intervention will be prospectively evaluated 6 months after the intervention.",[26],[505,506,507,508,509,510],"nsLTP allergy","Dietary intervention","Pectin","Microbiome","Immunomodulation","Food allergy treatment","2025-06-11",{"date":513,"type":37},"2025-06-15",{"date":221,"type":37},{"date":516,"type":22},"2026-11-30",{"name":518,"class":70},"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":16,"sex":17,"minAge":160,"maxAge":234,"enrollmentInfo":525,"targetDuration":4,"studyType":57,"phases":527,"briefSummary":529,"conditions":530,"keywords":531,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"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.",{"count":526,"type":22},40,[528],"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.",[26,139],[26],"2025-04-29",{"date":534,"type":37},"2025-05-02",{"date":536,"type":37},"2024-10-01",{"date":538,"type":22},"2026-12",{"name":540,"class":70},"National Jewish Health",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":12,"sex":17,"minAge":160,"maxAge":346,"enrollmentInfo":548,"targetDuration":4,"studyType":57,"phases":549,"briefSummary":550,"conditions":551,"keywords":552,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":226},"100567187","effectiveness-and-safety-of-milk-ladders-in-children-with-ige-mediated-cows-milk-protein-allergy-100567187","NCT06664918","Effectiveness and Safety of Milk Ladders in Children with IgE-Mediated Cow's Milk Protein Allergy","Effectiveness and Safety of the 4-Step Versus 6-Step Milk Ladder in Children with IgE-Mediated Cow's Milk Protein Allergy: Protocol for an Open-Label Randomised Controlled Trial","Inclusion Criteria:\n\n* Age between 1 and 5 years.\n* Diagnosis of IgE-mediated CMPA confirmed according to ESPGHAN guidelines, by a positive OFC with CMPs. In high-risk children (i.e., with a history of anaphylaxis), diagnosis based on positive skin prick testing and\u002For elevated specific IgE to CMPs is sufficient.\n* On a therapeutic elimination diet for at least 6 months or up to 12 months of age.12\n* Eligible regardless of the risk of systemic reaction (anaphylaxis) and asthma.\n* Good overall health status.\n* Parents without language barriers.\n* Written informed consent signed by parents.\n* Good cooperation with the child's guardians.\n\nExclusion Criteria:\n\n* Uncontrolled asthma, defined as the presence of shortness of breath, chest tightness, cough, and\u002For auscultatory changes despite treatment.\n* Signs of exacerbation of a chronic disease.\n* Signs of acute infectious disease (i.e., acute runny nose, cough, subfebrile fever, or fever).\n* Signs of exacerbation of another allergic disease (i.e., conjunctivitis, allergic rhinitis, atopic dermatitis).\n* Anaphylaxis due to CMPs in the last 6 months.\n* Used antihistamines within 3-10 days before the challenge (depending on the characteristics of the drug and the reason for use).\n* Acquired tolerance to baked CMPs or higher steps of the milk ladder.\n* Use of immunosuppressive drugs or immunotherapy",{"count":56,"type":22},[59],"Cow's milk protein allergy (CMPA) is one of the most common food allergies in early childhood. The first-line treatment of CMPA is the elimination of cow's milk proteins (CMPs) from the child's or maternal diet.\n\nAvailable data from the literature indicate that most children with CMPA acquire tolerance to CMPs with age. An assessment of tolerance acquisition to CMPs is commonly performed using milk ladder. However, scientific evidence regarding the effectiveness and safety of the milk ladder in children with CMPA is limited. Currently, there is no standardised milk ladder protocol, and different versions of the ladder and recommend by scientific societies in various countries.\n\nThis study aims to assess the effectiveness and safety of the 4-step milk ladder (4-ML) compared to the 6-step milk ladder (6-ML) in children with IgE-mediated CMPA. This is an open-label, randomised superiority trial with two parallel arms and a 1:1 allocation ratio.",[166,26],[553,480,554],"IgE-mediated cow's milk allergy","milk ladder","2025-03-13",{"date":557,"type":37},"2025-03-18",{"date":559,"type":37},"2024-12-03",{"date":561,"type":22},"2029-03",{"name":464,"class":70},{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":17,"minAge":131,"maxAge":19,"enrollmentInfo":570,"targetDuration":4,"studyType":57,"phases":571,"briefSummary":572,"conditions":573,"keywords":4,"overallStatus":455,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":4},"100577018","endomicroscopic-evaluation-of-food-induced-gastrointestinal-mucosal-alteration-100577018","NCT06792838","Endomicroscopic Evaluation of Food-induced Gastrointestinal Mucosal Alteration","A Multicenter Ambispective Evaluation of Atypical Food Allergies In-vivo Utilizing Confocal Laser Endomicroscopy in Pediatric and Adult Patients","Inclusion Criteria:\n\nPatients must meet all of the following criteria to be included in the study\n\n* Adults and children presenting with a prolonged history of IBS-like symptoms (as described by Rome IV criteria) related to food intake.\n* A negative or very low\u002Flow levels of Ig-E food allergy panel or negative skin prick test\n* Negative celiac disease work up\n\nExclusion Criteria:\n\n* If patient had a previous Esophagogastroduodenoscopy (EGD) and Colonoscopy with biopsy positive for any chronic inflammatory condition for eg. Inflammatory Bowel Disease (IBD), the patient will be excluded.\n* Pregnant or nursing at the time of CLE.\n* Known allergy to fluorescein.\n* Impaired renal function tests.\n* Active GI bleeding.",{"count":320,"type":22},[59],"The overarching goal of this study is to establish a first ever registry in the U.S. to collect outcomes data to evaluate changes in the gastrointestinal (GI) mucosa following direct food application utilizing Confocal Laser Endomicroscopy (CLE). This will be assessed in pediatric and adult patients who present to the outpatient clinic with persistent irritable bowel syndrome-like symptoms while testing negative for celiac disease and have either negative or very low\u002Flow levels of Immunoglobulin E (IgE) serological tests.",[574,26],"Irritable Bowel Syndrome","2025-02-21",{"date":577,"type":37},"2025-02-24",{"date":579,"type":22},"2025-03",{"date":581,"type":22},"2034-09",{"name":583,"class":70},"Cook Children's Health Care System",{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":4,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":591,"targetDuration":131,"studyType":23,"phases":4,"briefSummary":593,"conditions":594,"keywords":597,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":45},"100530909","epap-interviewstudy-100530909","NCT06192914","EPAP, Interviewstudy","Prospective Survey of the Repeated Occurrence of Anaphylactic Reactions in Patients with Food Allergies","Inclusion Criteria:\n\n* anaphylactic reaction to peanuts, other legumes, tree nuts, seeds (e.g. sesame seed, sunflower seed), cereals (e.g. wheat, oat) or pseudocereals (e.g. quinoa)\n* participation in the European Anaphylaxis Registry (Clinical Trials Identifier: NCT05210543)\n* possibility and consent to receive links to the follow-up electronic surveys via e-mail and fill out the questionnaires electronically\n\nExclusion Criteria:\n\n* if inclusion criteria are fulfilled there are no further exclusion criteria",{"count":592,"type":22},322,"The goal of this observational study is to learn about repetitive anaphylactic reactions in food allergic patients and to compare the frequency of repetitive reactions between different elicitors in food allergic patients. The main question it aims to answer are:\n\n• Is there an elicitor specific difference in the occurrence of anaphylactic reactions once the elicitor has been identified and the patient received counselling about its avoidance?\n\nParticipants will answer questionnaires via a link they will receive via e-mail at baseline and 3, 6, 12 and 24 months after inclusion in the study.",[26,431,595,596],"Allergy","Anaphylactic Shock",[26,598,599],"Repetitive Reactions","Quality of Life","2025-02-11",{"date":602,"type":37},"2025-02-13",{"date":604,"type":37},"2022-03-01",{"date":606,"type":22},"2029-02-28",{"name":608,"class":70},"Charite University, Berlin, Germany",{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":613,"acronym":4,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":17,"minAge":615,"maxAge":132,"enrollmentInfo":616,"targetDuration":4,"studyType":57,"phases":618,"briefSummary":619,"conditions":620,"keywords":621,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":45},"100541334","efficacy-of-cashew-nut-protein-immunotherapy-100541334","NCT06328504","Efficacy of Cashew Nut Protein Immunotherapy","Inclusion Criteria:\n\n* age between 4 and 17 years,\n* IgE (immunoglobulin E) -mediated cashew allergy confirmed with positive skin prick tests with cashew allergens (diameter of the wheal greater than 3mm) and\u002For specific IgE (immunoglobulin E) level greater than 0.35-kilo units of Allergen per liter (kUA\u002Fl),\n* allergic reaction to cashew protein during oral food challenge (OFC),\n* Signed Informed Consent by parent\u002Flegal guardian and patient aged \\>16 years old,\n* Patient's and caregivers' cooperation with the researcher.\n\nExclusion Criteria:\n\n* no confirmed allergy to cashew,\n* negative provocation test with cashew,\n* severe asthma,\n* mild\u002Fmoderate asthma poorly controlled: FEV1 (forced expiratory volume at one second) \\\u003C80% (less than 5 perc), FEV1\u002FFVC (forced expiratory volume at one second\u002Fforced vital capacity) \\\u003C75% (less than 5 perc), hospitalization for asthma exacerbation in the past 12 months,\n* oral\u002Fsublingual\u002Fsubcutaneous immunotherapy to other allergens during the study,\n* eosinophilic gastroenteritis,\n* chronic diseases requiring ongoing treatment, including heart disease, epilepsy, metabolic diseases, diabetes,\n* taking medications:\n\n  * oral, daily steroid therapy \\>1 month in the past 12 months,\n  * a minimum of 2 times oral steroid therapy (a period of at least 7 days) in the past 12 months,\n  * one-time oral steroid therapy (min. 7 days) in the last 3 months,\n  * biological treatment,\n  * need to take antihistamines continuously,\n  * therapy with β-blockers, ACE-inhibitors (angiotensin converting enzyme), calcium channel inhibitors,\n* pregnancy,\n* lack of consent to participate in the study,\n* lack of patient cooperation.","4 Years",{"count":617,"type":22},39,[59],"It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with cashew protein compared with standard treatment (elimination diet) in pediatric patients with cashew allergy.",[26],[622,141,623,480],"cashew","immunotherapy","2025-01-29",{"date":626,"type":37},"2025-01-30",{"date":628,"type":37},"2024-03-28",{"date":630,"type":22},"2027-04-21",{"name":464,"class":70},{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":17,"minAge":640,"maxAge":641,"enrollmentInfo":642,"targetDuration":4,"studyType":57,"phases":644,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":45},"100499595","clinical-versus-home-introduction-of-milk-in-children-with-non-ige-mediated-cows-milk-allergy-100499595","NCT05785299","Clinical Versus Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy","Evaluation of the Outcome of Clinical or Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy (ENIGMA Trial)","ENIGMA","Inclusion Criteria:\n\n* maximum age of eighteen months;\n* suspected to be allergic for cow's milk (based on medical history);\n\nExclusion Criteria:\n\n* children older than the age of eighteen months;\n* sensitised for cow's milk (i.e. SPT \\>3mm (in combination with positive control ≥3mm) or specific IgE \\>0.35 kU\u002FL)\n* patient suffers from acute (i.e. within one hour after cow's milk had been eaten) and moderate-severe IgE-mediated symptoms after ingestion of cow's milk\n* patient suffers from symptoms according to the FPIES criteria after ingestion of cow's milk\n* patient uses beta blockers and\u002For prednisolone;\n* patient suffers from uncontrolled respiratory symptoms or severe eczema or a chronic condition because of which the patients cannot be included as judged by the treating physician;\n* parents are unable to adequately report the occurrence of possible symptoms (e.g. insufficient language proficiency).","1 Month","18 Months",{"count":643,"type":22},120,[59],"There are a lot of parents who believe that their child may not tolerate cow's milk because they develop symptoms such as redness of the skin or they may vomit. It is not always easy to find out if these infants should indeed avoid drinking cow's milk or that the symptoms are caused by something else, for instance because they have a viral illness. The goal of the investigators is to find out if cow's milk should be introduced in the hospital or if it can also be advised to perform the introduction at home to determine if an infant can drink cow's milk without developing symptoms. Half of the participants will drink cow's milk in the hospital. This test is performed on two days. On one of the days cow's milk will be offered. On the other day a look-alike substance is offered. The other half of the participants will drink cow's milk at home by starting to drink a little bit of milk and in a few steps drink a normal bottle of cow's milk. The main question is whether both tests can be used to find out if an infant can drink cow's milk without developing symptoms.",[166,26],"2024-11-21",{"date":649,"type":37},"2024-11-25",{"date":651,"type":37},"2023-10-09",{"date":653,"type":22},"2026-06-01",{"name":655,"class":70},"Martini Hospital Groningen",{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":661,"acronym":662,"eligibilityCriteria":663,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":95,"enrollmentInfo":664,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":665,"conditions":666,"keywords":669,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":673,"lastUpdatePostDateStruct":674,"startDateStruct":676,"completionDateStruct":678,"leadSponsor":680,"locationsCount":45},"100564885","observatory-of-the-lille-paediatric-allergy-unit-100564885","NCT06634992","Observatory of the Lille Paediatric Allergy Unit","Paediatric Observatory of Oral Food Tolerance Induction in the Allergy Department of the Saint-Vincent de Paul Hospital in Lille","PAUL","Inclusion criteria:\n\n* patient under 15 years and 9 months,\n* positive diagnosis of food allergy (positive food challenge test or \"highly probable allergy\", defined by a convincing history, a positive prick test and IgE \\> 0.35 kUA\u002FL),\n* eligible for oral food challenge\n* accepting the following allergens : hazelnut, walnut, pistachio, cashew, peanut, cow's milk, wheat, egg, sesame, celery, fenugreek, pea, lentils or others\n\nExclusion criteria:\n\n* Opposition\n* Already received oral challenge for the same allergen.",{"count":301,"type":22},"The goal of this study is to set up a paediatric observatory within the allergology department of The saint Vincent Hospital, Lille. The study aims to:\n\n• Collect exhaustive prospective data from patients eligible for oral immunotherapy.\n\nThis prospective observatory will enable statistical analyses to be carried out on common food allergens such as hazelnut, cashew nut, pistachio and others.",[667,668,26],"Child Allergy","IgE-Mediated Allergic Process",[106,670,671,672],"Food challenge test","IgE-Mediated","Observatory","2024-10-08",{"date":675,"type":37},"2024-10-10",{"date":677,"type":37},"2022-01-01",{"date":679,"type":22},"2024-12-31",{"name":681,"class":70},"Lille Catholic University"]