[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cows-milk-protein-allergy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cows-milk-protein-allergy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100538259","hydrolysed-rice-formula-study-100538259",false,"NCT06288503","Hydrolysed Rice Formula Study","A Double-blind, Randomised-controlled Trial Evaluating a Hydrolysed Rice Formula Compared to a Cow's Milk Protein-based Extensively Hydrolysed Formula in Infants With Cow's Milk Allergy","Inclusion Criteria:\n\n* Male or female\n* Aged 0-13 months\n* Presenting to primary or secondary care with symptoms\u002Fclinical history suggestive of CMA\n* Will receive at least 30% of energy requirements from the study formula\n* Written informed consent from parent\u002Fcarer\n\nExclusion Criteria:\n\n* Severe CMA (including anaphylaxis) and\u002For requiring an AAF\n* Faltering growth (based on NICE guidelines36 - Appendix 1)\n* Previous allergy to any study product ingredients (including whey hydrolysate and\u002For rice)\n* Primary lactose intolerance\n* Food Protein-Induced Enterocolitis Syndrome (FPIES)\n* Exclusively breast fed\n* Severe concurrent or chronic disease or genetic syndrome that may impact growth or other outcomes\n* Severe hepatic or renal insufficiency\n* Premature infants (born \\\u003C37 weeks) with a corrected age of \\\u003C4 weeks\n* Requirement for any parenteral nutrition\n* Participation in other clinical intervention studies within 1 month of recruitment\n* Concern around the willingness\u002Fability of the caregiver to comply with the study protocol and\u002For study requirements","ALL","0 Months","13 Months",{"count":20,"type":21},86,"ESTIMATED","INTERVENTIONAL",[24],"NA","This non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day intervention period followed by a 2-month follow-up period in infants 0-13 months of age presenting with symptoms\u002Fclinical history suggestive of cow's milk allergy. The primary outcome is growth, and secondary outcomes are gastrointestinal tolerance, and differences in intake, allergic symptoms, parental QOL, acceptability, dietary intake, and safety.",[27],"Cow's Milk Protein Allergy","RECRUITING","2026-04-09",{"date":31,"type":32},"2026-04-13","ACTUAL",{"date":34,"type":32},"2024-02-01",{"date":36,"type":21},"2027-07",{"name":38,"class":39},"Nutricia UK Ltd","INDUSTRY",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":52,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100627446","post-failure-stepwise-heat-denaturated-protein-introduction-for-tolerance-induction-in-cows-milk-allergy-observational-cohort-study-100627446","NCT07448740","Post-failure Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Cow's Milk Allergy Observational Cohort Study","Post-TEHITI","Inclusion Criteria:\n\nParticipants eligible for inclusion in this study must meet all of the following criteria:\n\n* participation in s68299\n* failure to challenge test with unheated cow's milk\n* passed challenge test with unheated cow's milk but with symptoms developing between challenge and termination visit related to cow's milk intake at home\n\nExclusion Criteria:\n\nParticipants eligible for this study must not meet any of the following criteria:\n\n* Subjects not priorly enrolled in s68299\n* Subjects enrolled in s68299 who passed the challenge test and have no complaints upon regular cow's milk consumption at termination visit\n* Subjects who refuse to consent\u002Fassent with the study","1 Year","18 Years",{"count":51,"type":21},30,"48 Months","OBSERVATIONAL","Subjects who failed to become tolerant within 12 months after randomization within one of the three arms in the TEHITI study, can participate in the post-TEHITI observational trial to study the natural tolerance induction process.",[27],"2026-02-28",{"date":58,"type":32},"2026-03-04",{"date":60,"type":32},"2025-03-31",{"date":62,"type":21},"2030-10-24",{"name":64,"class":65},"Universitaire Ziekenhuizen KU Leuven","OTHER",5,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100608243","dietary-restriction-efficiency-assessment-in-cmpa-100608243","NCT07199023","Dietary Restriction Efficiency Assessment in CMPA","Dietary Restriction Efficiency Assessment of Different Hypoallergenic Formulas in Patients With Suspected Cow's Milk Protein Allergy","Inclusion Criteria:\n\nInfants aged 0-6 months; Diagnosed with suspected CMPA at the time of presentation; Artificially or mixed-feeding; Parents willing to sign a written informed consent and comply with the study protocol.\n\nExclusion Criteria:\n\nInfants currently receiving eHF or AAF formula; Mixed-feeding infants whose current daily formula intake is less than 50% of their total milk intake or less than 200 ml; Infants who have already started adding complementary foods; Infants who have experienced severe food allergy symptoms such as shock, severe vomiting, etc. after taking cow's milk protein; Infants with clinical manifestations of systemic allergic reaction or respiratory difficulties such as acute laryngeal edema or bronchial obstruction; Infants who have used prednisolone or anti-allergic drugs in the past 2 weeks; Infants with contraindications to eHF or AAF formula; Infants whose parents are unable to fully report the occurrence of possible symptoms (e.g., insufficient language skills); Infants with other serious diseases, including but not limited to growth retardation, metabolic disorders, kidney disease, congenital heart disease, medical conditions requiring hospitalization for more than 2 weeks, etc.; Infants whose mothers are unable to avoid necessary foods when mixed-feeding.","6 Months",{"count":76,"type":21},360,[24],"This clinical trial aims to evaluate and compare the efficacy of amino acid formula (AAF) and extensively hydrolyzed formula (eHF) in relieving symptoms in infants suspected of cow's milk protein allergy (CMPA) during the diagnostic elimination diet phase. The study will also assess treatment compliance, economic costs, and develop a CMPA screening score suitable for Chinese infants.\n\nEligible infants (0-6 months old) will be randomized to receive either AAF or eHF for at least 2 weeks. Symptom improvement will be evaluated, followed by an oral food challenge (OFC) to confirm CMPA diagnosis. Infants in the eHF group who do not improve may switch to AAF for further evaluation. The total duration of participation is approximately 6 to 8 weeks.\n\nThe study aims to provide evidence-based data to optimize diagnostic pathways and improve quality of life for infants with CMPA.",[27],[81,82,83],"Amino Acid Formula","Extended Hydrolyzed Formula","Cow's milk protein allergy","NOT_YET_RECRUITING","2025-11-13",{"date":87,"type":32},"2025-11-17",{"date":89,"type":21},"2026-01-01",{"date":91,"type":21},"2027-12-31",{"name":93,"class":65},"Ruijin Hospital"]