[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cows-milk-allergy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cows-milk-allergy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,78],{"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},"100551165","infant-formula-in-infants-and-children-with-cows-milk-allergy-100551165",false,"NCT06456541","Infant Formula in Infants and Children With Cow's Milk Allergy","Determination of Hypoallergenicity of an Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy","Inclusion Criteria:\n\n* Participant's parent(s) is\u002Fare willing for their child to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment:\n\n  1. Physician diagnosis of IgE-mediated CMA, according to the participant's clinical history (e.g. gastrointestinal symptoms, hives, respiratory symptoms or angioedema) AND, detectable serum milk-specific IgE \\>0.7 kUᴀ\u002FL or positive skin prick test wheal ≥5 mm;\n  2. Documentation of milk-specific serum IgE \\>15 kUᴀ\u002FL or \\> 5 kUᴀ\u002FL if younger than 1 year;\n  3. Documented cow's milk skin prick test wheal \\>10mm;\n  4. Physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms.\n* Participant's parent(s) agree for their child to stop oral steroid use within 14 days and antihistamine use within 7 days prior to confirmation of diagnosis and food challenges.\n* Participant had followed a strict cow's milk protein-free diet for at least 2 weeks prior to enrollment.\n* Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study.\n* Participant is between 3 months and 12 years of age at enrollment.\n* Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee\u002FInstitutional Review Board (IEC\u002FIRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.\n\nExclusion Criteria:\n\n* Participant is partially or exclusively breastfed at the time of enrollment.\n* Participant is consuming an amino acid-based formula due to failure on an extensively hydrolyzed formula.\n* Significant chronic medical diseases including major chromosomal or congenital anomalies, gastrointestinal diseases, or abnormalities other than CMA, immunodeficiencies, unstable asthma, eczema and\u002For food allergies treated with biologics (omalizumab or other monoclonal antibody), FPIES, eosinophilic esophagitis, and severe uncontrolled eczema.\n* Previous severe anaphylactic reaction to cow's milk within the last two years.,\n* An adverse medical history or current condition that is thought by the investigator to have potential for effects on tolerance or the hypoallergenicity test.\n* Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent.\n* Participant is consuming baked milk products.\n* Use of and\u002For changing dose of high potency steroids.","ALL","3 Months","12 Years",{"count":20,"type":21},61,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.",[27],"Cow's Milk Allergy","RECRUITING","2026-05-11",{"date":31,"type":32},"2026-05-13","ACTUAL",{"date":34,"type":32},"2024-10-01",{"date":36,"type":21},"2029-01",{"name":38,"class":39},"Abbott Nutrition","INDUSTRY",9,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":64,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100592413","phase-4-pasteurised-donor-human-milk-supplementation-for-term-babies-100592413","NCT06993103","Pasteurised Donor Human Milk Supplementation for Term Babies","A Randomised Controlled Trial of Pasteurised Donor Human Milk as Supplementary Nutrition for Infants Born to Women With Diabetes in Pregnancy.","PRESENT","Inclusion Criteria:\n\nEach participant must meet all the following criteria to be enrolled in this trial:\n\n* Mother is \\>18 years at the time of consent\n* Mother has diabetes in pregnancy (type 1, type 2 or gestational diabetes)\n* Mother intends to breastfeed for at least 6 weeks at the time of consent.\n* Infant is born at ≥ 37 weeks and weighs \\> 2.5kg\n* Clinician caring for infant decides that supplementary nutrition (in addition to maternal breast milk) is required within the first 48 hours after birth.\n* Parent\u002Fs provide\u002Fs a signed and dated informed consent form and has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.\n\nExclusion Criteria:\n\nMother\u002Finfant pairs meeting any of the following criteria will be excluded from the trial:\n\n* Multiple pregnancy\n* Mother has a condition that precludes maternal breast milk consumption e.g. HIV, receiving chemotherapy\n* Infant has clinically significant congenital abnormality interfering with effective breastfeeding or breast milk consumption (e.g., cleft lip and palate, metabolic disorder) and\u002For requiring immediate care in a neonatal unit (e.g., congenital heart disease).\n* Infant has received infant formula prior to randomisation.\n* Infant admitted to neonatal intensive care prior to randomisation.\n* More than 48 hours old at the time of recruitment","0 Hours","48 Hours",{"count":52,"type":21},1444,[54],"PHASE4","PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy.\n\nThere will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 \\& 6 weeks and 6 \\& 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life \\[including anxiety and depression symptoms and health-related quality of life\\] along with infant cow's milk allergy symptoms.",[57,58,59,60,61,62,63],"Neonatal Hypoglycemia","Metabolic Complication","Cows Milk Allergy","Hospital Length of Stay","Neonatal Intensive Care Unit","Breastfeeding","Mental Health Issue",[65,66],"Pasteurised donor human milk","Donor breastmilk","2026-01-29",{"date":69,"type":32},"2026-02-02",{"date":71,"type":32},"2025-12-04",{"date":73,"type":21},"2028-12",{"name":75,"class":76},"The University of Queensland","OTHER",4,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":16,"minAge":4,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100566247","early-supplementation-for-cows-milk-allergy-prevention-100566247","NCT06652698","Early Supplementation for Cow's Milk Allergy Prevention","Early Supplementation for Cow's Milk Allergy Prevention in Breastfed Infants in Poland (ESCAPE-PL): a Protocol for Randomised Controlled Trial","ESCAPE-PL","Inclusion criteria:\n\n1. Healthy newborns of mothers who express the intention to exclusively breastfeed for first 6 months of infant's life\n2. Full-term infants (defined as gestational age of at least 37 weeks)\n3. Infant birth weight at least 2500 g and ≤ 4500 g\n4. Age at enrolment \\\u003C24 h of life\n5. Regardless of any atopic condition in parents\n6. Written informed consent of the caregiver\n\nExclusion criteria:\n\n1. Infants of parents who intend to partially or fully formula feed\n2. Serious congenital anomalies or any other medical condition that would preclude the consumption of any of the study formulas, or interfere with nutrition or growth\n3. Contradictions to exclusive breastfeeding\n4. Multiple pregnancy",true,"24 Hours",{"count":89,"type":21},1000,[24],"Cow's milk allergy (CMA) is a common food allergy in infants and young children that can have a significant impact on the individual and their family due to dietary restrictions, risk of nutritional deficiencies, social limitations, and decreased quality of life. It also represents a financial burden for families and healthcare resources.\n\nThere is an ongoing debate about the significance of early exposure to cow's milk proteins within hours or days after birth and its relationship to the risk of developing CMA later in life. Current recommendations for early introduction of cow's milk proteins in infants who cannot be breastfed vary and are inconsistent due to a lack of clear evidence. This knowledge gap underscores the need for further research to provide a definitive understanding of the relationship between early exposure to cow's milk proteins and the development of CMA, which will ultimately inform evidence-based prevention strategies to improve the health and well-being of affected individuals and their families.\n\nThis trial aims to investigate whether early supplementation with various nutritional interventions (cow's milk formula \\[CMF\\], amino acids formula \\[AAF\\], donor human milk \\[DHM\\], or high-pressure processed \"pascalized\" donor human milk \\[DHM-P\\]) could serve as an effective strategy for the primary prevention of CMA in breastfed neonates.\n\nThis study is an open-label randomized, controlled, head-to-head trial with four parallel arms and allocation 1:1:1:1.",[93,27],"Food Allergy","NOT_YET_RECRUITING","2025-07-14",{"date":97,"type":32},"2025-07-17",{"date":99,"type":21},"2025-07",{"date":101,"type":21},"2031-03",{"name":103,"class":76},"Medical University of Warsaw",1]