[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Teyi Yinuo Health Technology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100658698","terifort-1-study-efficacy-and-safety-of-an-extensively-hydrolyzed-formula-in-the-management-of-cows-milk-protein-allergy-in-young-children-a-prospective-single-arm-interventional-study-terifort-1-100658698",false,"NCT07855796","TeriFort 1+ Study: Efficacy and Safety of an Extensively Hydrolyzed Formula in the Management of Cow's Milk Protein Allergy in Young Children: A Prospective, Single-Arm Interventional Study (TeriFort 1+)","Efficacy and Safety of an Extensively Hydrolyzed Formula in the Management of Cow's Milk Protein Allergy in Young Children: A Prospective, Single-Arm Interventional Study","Inclusion Criteria:\n\n* 12 months≤ Age \\\u003C36 months at enrollment.\n* Born at term at 37 \\~ 42 weeks of gestation, with birth weight 2,500\\~4,000g.\n* Diagnosed with or highly suspected mild-to-moderate CMPA by a physician, meeting any of the following prior to enrollment:\n\n  1. Positive serum cow's-milk-specific IgE (sIgE) \\>0.35 kUA\u002FL (\\>0.7 kIU\u002FL), combined with a detailed medical history; or a positive skin prick test (SPT);\n  2. Positive result from a cow's milk protein elimination-challenge test;\n  3. A documented medical history confirming CMPA within the 2 weeks prior to enrollment.\n* Hospitalization is not required and home intervention is considered appropriate by the investigator.\n* Written informed consent signed by a parent or legal guardian.\n\nExclusion Criteria:\n\n* History of severe cows-milk-induced allergic reaction, such as anaphylactic shock.\n* Underlying disease or history that may increase risk or affect gastrointestinal tolerance, growth, or development, including chronic systemic disease, congenital heart disease, chronic inflammatory bowel disease, malignant tumor, gastrointestinal malformation, or major congenital malformation.\n* Laboratory abnormalities judged by the investigator to make participation inappropriate.\n* Use of an extensively hydrolyzed formula or amino-acid formula within the preceding month.\n* Participation in another interventional clinical trial within the preceding 90 days or currently.\n* Inability to complete scheduled study visits\n* Known intolerance to another ingredient in the study formula\n* Any other condition judged inappropriate by the investigator.","ALL","12 Months","36 Months",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to evaluate the clinical effect, as reported by physicians, of an extensively hydrolyzed formula in young children aged 1\\~3 years with diagnosed with or highly suspected CMPA in a real-world clinical practice setting. The study will also evaluate the growth parameters, stool frequency and consistency, formula intake volume, gastrointestinal tolerance (including fussiness, flatulence, colic) and sleep disturbances, and any adverse events that may arise during the intervention period. This is a prospective, single-arm study including 50 young children at 1 hospital in China. Each participant will be followed for 90 days.",[27],"Cow's Milk Protein Allergy (CMPA)",[29,30,31,32,33],"eHF","CMPA","Modified CoMiSS","SCORAD","IGSQ","NOT_YET_RECRUITING","2026-09-28",{"date":37,"type":38},"2026-10-02","ACTUAL",{"date":40,"type":21},"2026-11",{"date":42,"type":21},"2027-12",{"name":44,"class":45},"Shanghai Teyi Yinuo Health Technology Co., Ltd.","INDUSTRY",""]