[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647648":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":39,"collaborators":25,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":25,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":25,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":25,"overallStatus":60,"whyStopped":25,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":25},{"fullName":5,"class":6},"Société des Produits Nestlé (SPN)","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Test Formula","EXPERIMENTAL","New generation eHF",[13],"Dietary Supplement: New generation eHF",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Formula","ACTIVE_COMPARATOR","Commercial eHF",[19],"Dietary Supplement: Commercial eHF",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","New generation of a whey-based eHF formula intended for the dietary management of infants with CMPA.",[9],null,{"type":22,"name":17,"description":27,"armGroupLabels":28,"otherNames":25},"Commercial whey-based eHF formula intended for the dietary management of infants with CMPA.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Kamila Laskowska","CONTACT","41 21 785 87 32","kamila.laskowska@rd.nestle.com",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Giulia Ingrassia","+41 21 785 92 23","giuliamarialaura.ingrassia@rd.nestle.com",{"type":40,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100647648","growth-and-safety-outcomes-in-infants-with-cows-milk-protein-allergy-cmpa-fed-a-novel-extensively-hydrolyzed-formula-ehf-100647648",false,"NCT07711938","Growth And Safety Outcomes In Infants With Cow´s Milk Protein Allergy (CMPA) Fed A Novel Extensively Hydrolyzed Formula (eHF)","A Randomized, Double-Blind, Controlled Study to Compare Growth, Tolerability, and Safety of a Novel, Extensively Hydrolyzed Formula (eHF) Versus a Standard eHF in Full Term Infants With Cow's Milk Protein Allergy (CMPA)","Inclusion Criteria:\n\n1. Full-term infant(gestational age ≥37 weeks and ≤42 weeks).\n2. Birth weight ≥2500 g and ≤4500 g.\n3. Parent(s)\u002FLAR deemed able to provide written informed consent for participation of their infant in the study (in the opinion of the investigator).\n4. Participant aged ≥29 days (\\>4 weeks) and \\\u003C5 months (≤22 weeks) at time of enrollment.\n5. Not breastfed at time of Screening Visit.\n6. History of an immediate-type (IgE-mediated) allergic reaction to a cow's milk-containing food or at least 2 persistent severe symptoms suggestive of delayed-onset (non-IgE-mediated) CMPA.\n\nExclusion Criteria:\n\n1. Prior use of eHF, HRF or AAF for more than 2 weeks before randomization.\n2. Congenital illness or malformation that may affect growth, or significant pre-natal and\u002For serious post-natal disease other than CMPA before randomization (per investigator's medical decision).\n3. Demonstrated chronic malabsorption not due to CMPA.\n4. History of severe anaphylaxis to CMP.\n5. Infants whose parent(s)\u002FLAR cannot be expected to comply with study procedures.\n6. Currently participating or having participated in another clinical study since birth.\n7. Infants with a history of confirmed food protein induced enterocolitis syndrome due to other foods than CMP or Heiner syndrome.\n8. Infants with history of oral immunotherapy for CMPA.\n9. Diagnosed eosinophilic esophagitis.\n10. Received systemic oral or injected corticosteroids for more than 3 days (72 hours) within 2 weeks prior to the Screening Visit (topical corticosteroids allowed).\n11. Received systemic antibiotics within 1 week prior to Screening Visit (topical antibiotics, e.g., mupirocin allowed).\n12. Infants who are currently receiving treatment with immunomodulators (immunoglobulins, allergen extracts, or similar) or immuno-suppressants (azathioprine, cyclosporine or similar) within 2 weeks of Screening Visit (topical cyclosporine, tacrolimus, pimecrolimus or similar topical eczema treatments allowed), as well as infants with immune disorders which can compromise the immune function.\n13. Infants with a past or current disease or disorder which, in the opinion of the investigator or the sponsor either places the participant at risk because of participating in the study or may influence the results of the study, or the participant's ability to participate in the study (e.g., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine or metabolic disorders, malignancy, major physical impairment, immunodeficiency, infectious disease or abnormal laboratory results as per the investigator's judgment).\n14. Parent(s)\u002FLAR being in any relationship or dependency with the sponsor, and\u002For the investigator, and\u002For study staff.\n15. Underage parents (under 18 years old).","ALL","29 Days","22 Weeks",{"count":52,"type":53},410,"ESTIMATED","INTERVENTIONAL",[56],"NA","Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula.",[59],"Cow Milk Protein Allergy","NOT_YET_RECRUITING","2026-07-16",{"date":63,"type":64},"2026-07-17","ACTUAL",{"date":66,"type":53},"2026-07-01",{"date":68,"type":53},"2029-05-30",{"name":5,"class":6}]