[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cow-milk-protein-allergy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cow-milk-protein-allergy":28},{"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":4,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100564751","effect-of-a-hydrolyzed-rice-protein-based-formula-on-growth-tolerance-and-health-related-quality-of-life-in-infants-with-cows-milk-protein-allergy-100564751","NCT06633250","Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy.","Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy: a Randomized Nutritional Clinical Study","RIGHT-GO","Inclusion Criteria:\n\n1. Written informed consent has been obtained from at least one parent (or legally acceptable representative \\[LAR\\]), if applicable)\n2. Infant gestational age ≥ 37 completed weeks\n3. Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg\n4. Singleton birth\n5. Infant age ≤ 8 months\n6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk\n7. Suspected CMPA as per standard clinical practice and in conjunction with at least 2 symptoms present from the list shown below:\n\n   1. Inconsolable crying, regurgitation, liquid stools or constipation, skin atopic lesion, cow's milk provoked temporary urticaria\u002Fangioedema or vomiting, bloody streaks in stool, or respiratory symptoms\n   2. For diagnosis based on either a positive IgE blood test, skin prick test or food challenge, only at least 1 symptom from above list needs to be present\n8. Infant is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study\n9. Infant's parent(s)\u002FLAR is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol\n\nExclusion Criteria:\n\n1. History of intolerance to eHF formula\n2. Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies (based on medical history and\u002For commonly performed diagnostic criteria)\n3. Major gastrointestinal disease \u002F abnormalities (other than CMPA)\n4. Known or suspected lactose intolerance or malabsorption\n5. Known or suspected soy allergy\n6. Glucose-galactose malabsorption\n7. Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome).\n8. Immunodeficiency\n9. Persistent wheeze or chronic respiratory disease\n10. Severe uncontrolled eczema\n11. History of severe anaphylactic reaction (e.g., requiring ≥ 2 doses of epinephrine) to cow's milk or breast milk at any time prior to enrollment\n12. Weight-for-age value \\\u003C -2 or \\> 2 standard deviations from the WHO Child Growth Standards median at enrollment\n13. Height-for-age \\\u003C -2 or \\> 2 standard deviations from the WHO Child Growth Standards median at enrollment\n14. Infant's parent has other medical or psychiatric condition that, in the judgement of the investigator, would make the infant inappropriate for entry into the study\n15. Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment","8 Months",{"count":52,"type":22},104,[25],"The main purpose of this study is to demonstrate that the growth of infants fed with the Test Formula is non-inferior those fed with the Control Formula. The study will also evaluate the gastrointestinal tolerance, quatliy of life and acceptability of the new rice protein-based formula in infants with cow's milk protein allergy (CMPA).",[28],"RECRUITING","2025-12-18",{"date":59,"type":34},"2025-12-26",{"date":61,"type":34},"2024-10-25",{"date":63,"type":22},"2026-08",{"name":65,"class":41},"Société des Produits Nestlé (SPN)",19]