[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"food-hypersensitivity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:food-hypersensitivity":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,76,110,139],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100587885","phase-2-omalizumab-for-the-treatment-of-food-allergy-in-patients-with-elevated-total-ige-levels-100587885",false,"NCT06934200","Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels","Inclusion Criteria:\n\n* Age 1 to 55 years\n* A positive prick skin test (PST) with a wheal ≥ 6 mm to at least one of the relevant foods (peanut, cashew, walnut, egg, milk, or wheat)\n* Positive food-specific IgE (≥2.0 kilo units of allergen-specific IgE per liter (kUA\u002FL)) to at least one of the study specific foods\n* A weight \u002F IgE level that would have excluded the participant from the OUTMATCH study based on the dosing table noted above\n* Positive double-blind, placebo-controlled food challenge (DBPCFC) to one of the relevant foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg)\n\nExclusion Criteria:\n\n* Clinically significant laboratory abnormalities at screening.\n* Dose-limiting symptoms during the blinded food challenge to placebo during the screening DBPCFC.\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 or 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., oral immunotherapy (OIT), sublingual immunotherapy (SLIT), epicutaneous immunotherapy (EPIT) within 6 months of screening.\n* Treatment with monoclonal antibody therapy, such as omalizumab, dupilumab, benralizumab, mepolizumab, reslizumab, tezepelumab, or other immunomodulatory therapy within 6 months of screening.\n* Inability to discontinue antihistamines for minimum wash-out periods required for skin prick tests (SPTs) or oral food challenges (OFCs).\n* Pregnant or breastfeeding, or intending to become pregnant during the study\n* Evidence of clinically significant chronic disease.","ALL","1 Year","55 Years",{"count":19,"type":20},32,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","In this project, the investigators would like to learn if 24 weeks (about 5 and a half months) of omalizumab injections, given every 2 weeks, will be safe and effective for food allergic people who have a total immunoglobulin E (IgE) above the current FDA approved dosing regimen enabling a person to increase tolerance to the food(s) that the person is allergic to.\n\nThe investigators would also like to learn if participants who demonstrate increased tolerance to food after 24 weeks of omalizumab, can introduce the food into the diet utilizing an additional 8 weeks (about 2 months) of twice weekly omalizumab injections.",[26],"Food Hypersensitivity",[28],"omalizumab","RECRUITING","2026-06-05",{"date":32,"type":33},"2026-06-08","ACTUAL",{"date":35,"type":33},"2025-05-19",{"date":37,"type":20},"2027-10-15",{"name":39,"class":40},"Johns Hopkins University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":41},"100631487","recombinant-tropomyosin--and-hemocyanin-specific-ige-in-children-with-suspected-shrimp-allergy-100631487","NCT07501325","Recombinant Tropomyosin- and Hemocyanin-Specific IgE in Children With Suspected Shrimp Allergy","Diagnostic Value of Recombinant Tropomyosin- and Hemocyanin-Specific IgE for the Diagnosis of IgE-Mediated Shrimp Allergy in Children in Vietnam","Inclusion Criteria:\n\n* Children aged 1 to 16 years.\n* Evaluated at the Allergy Unit of Children's Hospital 1.\n* Clinical history suggestive of IgE-mediated shrimp allergy based on EAACI 2023 criteria, including at least 1 typical allergic symptom (urticaria, angioedema, vomiting, abdominal pain, diarrhea, cough, wheezing, dyspnea, or hypotension), symptom onset within 2 hours after shrimp ingestion, and recurrence on at least 2 separate exposures.\n* Parent or legal guardian able to provide written informed consent; child assent obtained when appropriate.\n\nExclusion Criteria:\n\n* Acute illness at the time of enrollment or challenge, including acute respiratory infection, acute gastrointestinal infection, or acute asthma exacerbation.\n* Severe chronic disease, including malignancy, severe liver or kidney disease, primary immunodeficiency, or significant heart disease affecting hemodynamic status.\n* Mental or behavioral disorder that prevents completion of study procedures.\n* Use of immunosuppressive medication (oral corticosteroids, cytotoxic drugs, or biologic agents) within 4 weeks before enrollment, or intravenous immunoglobulin within the previous 3 months.\n\nExclusion Criteria:\n\n* Acute illness at the time of enrollment or challenge, including acute respiratory infection, acute gastrointestinal infection, or acute asthma exacerbation; participants may be rescheduled after recovery.\n* Severe chronic disease, including malignancy, severe liver or kidney disease, primary immunodeficiency, or significant heart disease affecting hemodynamic status.\n* Mental or behavioral disorder that prevents completion of study procedures.\n* Use of immunosuppressive medication (oral corticosteroids, cytotoxic drugs, or biologic agents) within 4 weeks before enrollment, or intravenous immunoglobulin within the previous 3 months.","16 Years",{"count":51,"type":20},129,[53],"NA","This study will evaluate whether blood tests that measure IgE antibodies to two shrimp proteins, tropomyosin and hemocyanin, can help diagnose shrimp allergy in children. Children with suspected IgE-mediated shrimp allergy will undergo oral food challenge, skin prick testing, and blood sampling. Oral food challenge results will be used as the reference standard to determine whether these tests can accurately identify true shrimp allergy and help improve diagnosis in clinical practice.",[26,56],"Shellfish Allergy",[58,59,60,61,62,63,56,64,26,65],"Oral Food Challenge","Skin Prick Test","Tropomyosin","Hemocyanin","Specific IgE","Recombinant Allergen","Children","Shrimp Allergy","NOT_YET_RECRUITING","2026-03-31",{"date":69,"type":33},"2026-04-06",{"date":71,"type":20},"2026-04",{"date":73,"type":20},"2028-04",{"name":75,"class":40},"University of Medicine and Pharmacy at Ho Chi Minh City",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":83,"enrollmentInfo":84,"targetDuration":86,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":106,"locationsCount":109},"100619284","smash-study-to-evaluate-the-clinical-efficacy-of-an-extensively-hydrolysed-infant-formula-with-synbiotics-and-a-human-milk-oligosaccharide-hmo-in-infants-with-cows-milk-protein-allergy-cmpa-100619284","NCT07342621","SMASH: Study to Evaluate the Clinical Efficacy of an Extensively Hydrolysed Infant Formula With Synbiotics and a Human Milk Oligosaccharide (HMO) in Infants With Cow's Milk Protein Allergy (CMPA)","SMASH","Inclusion Criteria:\n\n* Infants under 10 months of age at study start (Visit 1).\n* Suspected or recently confirmed cow's milk protein allergy (CMPA), as determined by the investigator.\n* Already formula-fed, or parents\u002Flegal guardians have decided to initiate formula feeding.\n* Inclusion in the study coincides with the first prescription of a hypoallergenic formula.\n* Written informed consent obtained from parents or legal guardians in accordance with local regulations.\n\nExclusion Criteria:\n\n* Infants with functional gastrointestinal symptoms in whom atopy or food allergy is not suspected.\n* Infants who have previously used an extensively hydrolyzed formula (EHF), an amino acid-based formula (AAF), a rice hydrolysate formula, or a soy-based formula.\n* Infants who have previously used a partially hydrolyzed formula for the prevention of cow's milk protein allergy (CMPA).\n* Infants for whom an amino acid-based formula (AAF) is more appropriate as first-line management, including severe forms of CMPA.\n* Contraindications to the use of synbiotics (e.g., preterm infants \\\u003C40 weeks of corrected gestational age at study start, immunodeficiency, short bowel syndrome, parenteral nutrition, post-pyloric feeding, central venous catheter, oncology treatment, or graft-versus-host disease).\n* Any other condition, as assessed by the investigator, that contraindicates the use of an extensively hydrolyzed formula.\n* Any other circumstance, as assessed by the investigator, indicating that the parents or legal guardians are not capable of complying with the study procedures.","10 Months",{"count":85,"type":20},41,"4 Weeks","OBSERVATIONAL","Cow's milk protein allergy (CMPA) is one of the most common food allergies in infants, with an estimated prevalence between 2% and 5%. The number of diagnosed cases has increased in recent years, with clinical manifestations involving the gastrointestinal tract, respiratory system, skin, or systemic reactions. Dietary elimination of cow's milk protein remains the mainstay of treatment, using extensively hydrolyzed formulas (EHF) or amino acid-based formulas (AAF), depending on the severity of the allergy.\n\nThis study aims to evaluate the clinical effect, as reported by physicians, of an extensively hydrolyzed whey-based formula (Almirón Pepti Syneo®) containing a symbiotic mixture (scGOS\u002FlcFOS 9:1 and Bifidobacterium breve M-16V), the human milk oligosaccharide 2'-fucosyllactose (2'-FL), and a reduced amount of purified lactose, in infants with suspected or confirmed CMPA in a real-world clinical practice setting.\n\nThis is a prospective, longitudinal, open-label, single-arm, multicenter study including approximately 41 infants under 10 months of age at several primary care centers and one hospital in Valencia, Spain. Each participant will be followed for four weeks. A subgroup of participants will also provide stool samples to explore the effect of the study formula on gut microbiota composition.",[90,26,91,92],"Cow's Milk Protein Allergy (CMPA)","Infant Nutrition Disorders","Gut Microbiota",[94,95,96,97,98,99],"Extensively Hydrolyzed Formula","Synbiotics","Cow's Milk Protein Allergy","Real World Evidence","Microbiota","Gastrointestinal Symptoms","2026-01-05",{"date":102,"type":33},"2026-01-15",{"date":104,"type":33},"2025-02-07",{"date":71,"type":20},{"name":107,"class":108},"Outcomes'10","NETWORK",13,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":118,"targetDuration":120,"studyType":87,"phases":4,"briefSummary":121,"conditions":122,"keywords":128,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":41},"100412651","a-registry-for-the-food-allergy-community-100412651","NCT04653324","A Registry for the Food Allergy Community","The FARE Patient Registry: A Registry for the Food Allergy Community","FPR","Inclusion Criteria:\n\n* Individuals with diagnosed food allergy\n\nExclusion Criteria:\n\n* Individuals without food allergy",{"count":119,"type":20},23000,"5 Years","The FARE Patient Registry will serve as a prospective, observational food allergy reporting system that stores detailed health and other basic information about patients' real-world experiences with food allergies, to encourage open sharing of de-identified data and participation in clinical trials. The FARE Patient Registry intends to make and support scientific discoveries by enabling the food allergy community to participate directly in research.",[26,123,124,125,126,127],"Anaphylaxis","Eosinophilic Esophagitis","Food Sensitivity","Food Intolerance","Food Allergy in Infants",[129],"food allergy","2025-03-10",{"date":132,"type":33},"2025-03-12",{"date":134,"type":33},"2017-08-24",{"date":136,"type":20},"2027-08",{"name":138,"class":40},"Food Allergy Research & Education",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":146,"sex":15,"minAge":147,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":41},"100459223","mucosal-ige-to-improve-diagnosis-of-food-allergy-and-food-hypersensitivity-100459223","NCT05259826","Mucosal IgE to Improve Diagnosis of Food Allergy and Food Hypersensitivity","Improving the Diagnosis of Food Allergy and Food Intolerance by Determining Mucosal IgE and Inflammatory Markers and Validating With Intestinal in Vitro Organoids","Inclusion Criteria:\n\n* informed consent\n* patients with suspected food allergy or hypersensitivity\n* healthy controls with indications for endoscopic diagnostics, e.g. tumour history within the family, exclusion of gastritis\n\nExclusion Criteria:\n\n* pregnant person",true,"18 Years",{"count":149,"type":20},115,[53],"Aim of the study is to improve the diagnosis of food allergy and hypersensitivity. Intestinal homogenates will be used to determine total IgE, specific IgE, tryptase, histamine and inflammation parameters (IFNgamma, TNFalpha). These data will be correlated with serum values and disease status. In addition, organoids from duodenal tissue will be isolated and cultured in vitro and stimulated with the major food allergens. The gene and protein expression will be checked to identify relevant biomarkers.",[153,26],"Food Allergy",[155,156],"mucosal IgE","inflammation parameter","2024-07-03",{"date":159,"type":33},"2024-07-05",{"date":161,"type":33},"2022-02-01",{"date":163,"type":20},"2025-01-31",{"name":165,"class":40},"University of Erlangen-Nürnberg Medical School"]