[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fpies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fpies":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100640263","tolerance-and-growth-outcomes-of-an-extensively-hydrolysed-anti-regurgitation-casein-based-formula-in-infants-with-cows-milk-protein-allergy-100640263",false,"NCT07592182","Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy","Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy: a Clinical Evaluation","PANDA","Inclusion Criteria:\n\nI1. Age ≥ 1 month and \\\u003C 9 months, I2. Exclusively formula fed and planning to be formula-fed for the duration of the study (food diversification allowed),\n\nI3. With:\n\n1. a suspicion of CMPA based on suggestive allergic symptoms\n\n   * CoMISS score \\> 10\n   * And\u002For acute allergic symptoms\n   * And\u002For symptoms suggestive of a Food Protein-Induced Enterocolitis Syndrome (FPIES) (major criteria and \\\u003C3 minor criteria as per consensus guidelines) (Nowak-Węgrzyn et al. 2017; Beaudoin et al. 2025); OR\n2. a confirmed diagnosis of CMPA within the two months before inclusion:\n\n   * IgE-mediated CMPA (documented history of allergic reaction grade ≤ 3 according to the ordinal food allergy severity score oFASS-5 (Fernández-Rivas et al. 2022) following milk protein ingestion, and sensitization to CMP: blood IgE level specific to cow milk≥ 5 kU\u002FL, or positive skin prick test with papule with fresh cow's milk ≥ 8 mm\n   * or non-IgE-mediated CMPA (documented history of eviction\u002Freintroduction test concluding to CMPA),\n   * or FPIES (major criteria and ≥3 minor criteria as per consensus guidelines (Nowak-Węgrzyn et al. 2017; Beaudoin et al. 2025), I4. With a written informed consent signed by the father and mother or legal representative(s), I5. With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits, I6. With parents willing to achieve all study interventions, I7. At least one of the legal representatives is affiliated with a social security scheme.\n\nExclusion Criteria:\n\nE1. Birthweight \\\u003C 2500 g, E2. Gestational age \\\u003C 37 weeks, E3. Breastfeeding at the time of inclusion and throughout the study period, E4. Already fed with an AAF, or with the investigational formula EHF-AR, E5. History of anaphylactic reaction grade 4 or 5 according to classification oFASS-5 (Fernández-Rivas et al. 2022), or of severe FPIES (previous reaction with any change in behaviour from baseline, any pallor and dehydration requiring intravenous fluids), after mammalian milk exposure, E6. Diagnosed or reported fever and\u002For infectious diseases, or current systemic infections, or history of congenital infections,\n\nE7. History \u002F diagnosis of:\n\n1. GI disease or abnormalities (i.e. short bowel syndrome, chronic intestinal diseases, or GI malformations),\n2. Or Other malformations, congenital cardiovascular, kidney, liver, pancreas, metabolic or neurological diseases,\n3. Or Immunodeficiency, or chronic infection requiring long-term treatment,\n4. Or Genetic diseases and chromosomal abnormalities, E8. Suspected or confirmed food allergies or intolerances, other than CMPA, E9. Currently enrolled in another clinical study, or in exclusion period from a previous clinical study, E10. Whose legal representatives have psychological or linguistic incapability to sign the informed consent, E11. Impossibility to contact the legal representatives in case of emergency.\n\nAfter V1, the participant will be excluded from participation in this trial if he\u002Fshe fulfils the following criteria:\n\nE12. No allergic symptoms following the OFC with a standard CMPF.","ALL","1 Month","9 Months",{"count":21,"type":22},55,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study is designed as multicentric, interventional, with two successive randomised, double-blind, crossovers. The aim of the study is to demonstrate the tolerance of an extensively hydrolysed anti-regurgitation casein-based formula in infants with cow's milk protein allergy. After a confirmation of the diagnostic, this demonstration will be performed with oral food challenge. Secondarily, a long term tolerance phase will be performed to get growth outcomes with a consumption of the formula compared with a non-enriched formula.",[28,29],"Cow Milk Protein Allergy","FPIES","NOT_YET_RECRUITING","2026-05-21",{"date":33,"type":34},"2026-05-26","ACTUAL",{"date":36,"type":22},"2026-05",{"date":38,"type":22},"2028-07",{"name":40,"class":41},"Lactalis","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100563290","oral-immunotherapy-for-food-protein-induced-enterocolitis-syndrome-100563290","NCT06614244","Oral Immunotherapy for Food Protein Induced Enterocolitis Syndrome","Randomized Multicenter Trial of Oral Immunotherapy for Food Protein Induced Enterocolitis Syndrome","DOPAxSEA","Inclusion criteria\n\n* Pediatric patients (under 18 years of age) affected by persistent acute food protein-induced enterocolitis syndrome.\n* The last anamnestic acute episode must not be more than 1 month prior to the date of inclusion in the study. The anamnestic definition of acute episode will be based on the use of Miceli Sopo 2022 questionnaire for food protein-induced enterocolitis syndrome. In case it is not clear whether the disease is active or not, an oral food challenge will be performed to verify the possible acquisition of tolerance (a procedure that is part of the routine management for this allergy). Inclusion in the study must occur within 1 month of the possible failure of the aforementioned oral food challenge. Regarding patients with multiple FPIES (expected to be approximately 6% of the total patients included, a small minority), OIT will be started for the nutritionally most relevant food among those eligible.\n\nExclusion criteria\n\n* Absence of inclusion criteria.\n* Transition from acute FPIES to IgE-mediated AA.\n* Absence of informed consent approval by their caregivers.\n* Failure to use email by their caregivers.","3 Years","17 Years",{"count":53,"type":22},168,[25],"Food Protein Induced Enterocolitis Syndrome (FPIES) is a food allergy characterized by clinical manifestations of varying severity that can be, very rarely, severe to the point of leading to shock. Acute FPIES is nowaday the most common presentation of the disease. It is characterized by repeated, projectile vomiting (usually arising between 1 and 4 hours after ingestion of the culprit food) accompanied by pallor, hypotonia, and lethargy, with complete resolution of the aforementioned symptoms almost always within a few hours. Dietary management of FPIES currently involves avoiding allergens, offering complementary foods to encourage normal growth and providing families with individualized feeding plans. The elimination diet does not promote healing, it only prevents adverse reactions from culprit food ingestion. Recovery (i.e. tolerance to the culprit food) is achieved spontaneously over time. However, for some children, tolerance does not occur. These patients suffer from persistent FPIES. For these patients oral immunotherapy (OIT) is not yet planned and randomized and controlled studies are needed to demonstrate its efficacy and safety. The primary objective of the study will be to verify, with a multicenter, prospective, randomized study, stratified for the main 4 offending foods in Italy (cows milk, hens egg, fish and cereals), open-label and with an adequate sample size, the efficacy and safety of an OIT procedure in children affected by acute persistent FPIES. The comparison will be made between a population of children affected by acute persistent FPIES subjected to OIT for the offending food (DOPA group) and a population of children affected by acute persistent FPIES subjected to the traditional measure, i.e. the elimination diet for the offending food (Diet group).\n\nEfficacy will be measured through:\n\n* Comparison of the percentages of children who have increased their reactivity threshold even to the point of no adverse reactions to the offending food following the intake of a normal dose for their age in the two populations during treatment;\n* Comparison of the percentages of children who have reached tolerance towards the culprit food in the two populations;\n\nSafety will be measured through:\n\n\\- Comparison of the percentages of children who have presented adverse reactions following the ingestion (accidental in the Diet group and expected in the DOPA group) of the culprit food after enrollment in the study.\n\nThe definitions of desensitization and tolerance are taken from the EAACI 2018 guidelines on immunotherapy for IgE-mediated AA. In particular, desensitization corresponds to the absence of adverse reactions following the ingestion of the culprit food (in quantities up to a normal dose for age) during oral immunotherapy. This is a reversible or partially reversible clinical response that depends on continued exposure to the allergen. If the administration of the allergen is interrupted, the previous level of clinical reactivity may return. Tolerance corresponds to the absence of adverse reactions following the ingestion of the culprit food despite a period of absence of exposure.",[29],"2024-09-24",{"date":59,"type":34},"2024-09-26",{"date":61,"type":22},"2024-10-01",{"date":63,"type":22},"2028-03-31",{"name":65,"class":66},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",1]