[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nutricia Nutrition Clinique\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,38],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":5},"100522630","observatory-on-cows-milk-protein-allergy-100522630",false,"NCT06085118","Observatory on Cow's Milk Protein Allergy","Prospective National Observatory for Cow's Milk Protein Allergy.","OLAF","Inclusion Criteria:\n\n* Infants up to and including 8 months (up to 8 months and 29 days).\n* Initial diagnosis of allergy to cow proteins, suspected (clinical presumption) or confirmed.\n* Prescription of the substitution formula Pepticate® Syneo, according to the doctor's judgement, whether the child is under mixed or weaned breastfeeding.\n* Authorisation from a legal representative for the child to take part in the observatory and to collect personal information about the child and the family.\n* Membership of the social security system.\n\nExclusion Criteria:\n\n* Infants who have already received partial or total replacement infant formula (regardless of the type of infant formula).\n* Contraindication to the use of symbiotics (short small intestine, parenteral nutrition, post-pyloric feeding, central venous catheter) due to the use of Pepticate® Syneo®.\n* Diagnosis of severe cow protein allergy requiring an infant amino acid formula from the outset.\n* The child's legal guardian is protected (under legal protection, or deprived of liberty by judicial or administrative decision).\n* The legal representative is unable to understand the study protocol.","ALL","8 Months",{"count":20,"type":21},3000,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to describe the symptoms and their evolution up to the age of 5 years in a population of newly diagnosed infants with a suspected or confirmed allergy to cow proteins, for whom the doctor prescribed the Pepticate® Syneo® replacement formula as soon as they were diagnosed.\n\nThe Pepticate® Syneo® product is an advanced protein hydrolyzate, food type intended for special medical purposes. This is a product already available on the market.",[25],"Food Allergy","RECRUITING","2024-06-24",{"date":29,"type":30},"2024-06-25","ACTUAL",{"date":32,"type":30},"2024-06-17",{"date":34,"type":21},"2031-11",{"name":36,"class":37},"Nutricia Nutrition Clinique","INDUSTRY",{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":17,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":49,"conditions":50,"keywords":53,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100521891","management-of-drug-resistant-epilepsy-in-infants-and-children-a-real-life-study-of-the-use-of-the-ketogenic-diet-in-france-and-the-ketocal-range-in-its-maintenance-100521891","NCT06075485","Management of Drug-resistant Epilepsy in Infants and Children: a Real-life Study of the Use of the Ketogenic Diet in France and the KetoCal® Range in Its Maintenance","KEOPS","Inclusion Criteria:\n\n* Infants from 5 months and children up to 17 years of age (maximum 18 years minus 1 day).\n* With drug-resistant epilepsy according to ILAE (International League Against Epilepsy) criteria: persistence of epileptic seizures after failure of two appropriate antiepileptic drugs tried consecutively or in well-tolerated combination.\n* Indication for CR by a physician.\n* Parents (or legal guardians) able to set up and follow the diet, assessed during a joint doctor-dietician consultation.\n* Written authorization from one (or both) parents or the child's legal representative to collect personal information about their child.\n* Affiliation of the infant\u002Fchild with the social security system.\n\nExclusion Criteria:\n\n* Contraindication to ketogenic diet at initial assessment.\n* Children already on a ketogenic diet.\n* Parenteral nutrition.\n* Concurrent prescription of other foodstuffs intended for special medical purposes (DADFMS) such as KetoVie or Keyo.\n* Protected legal representative (under legal protection, or deprived of liberty by judicial or administrative decision).\n* Legal representative not covered by a social security scheme.\n* Legal representative unable to understand study protocol.\n\nAncillary study eligibility criteria :\n\n* Patients included in the study.\n* Continued on the ketogenic diet for at least 2 months.\n* Having consented to participate in the ancillary study.","5 Months","18 Years",{"count":48,"type":21},133,"This is a multicenter, prospective, observational, longitudinal study designed to describe the therapeutic value of the KetoCal® range in the maintenance of a ketogenic diet during the management of infants (from 5 months) and children up to 17 years of age (i.e. 18 years minus 1 day) with drug-resistant epilepsy.\n\nThis study is being conducted according to standard medical practice. No change in diagnostic or therapeutic management habits is imposed by this study. Quality of life questionnaires are the only additional procedures for this research.",[51,52],"Drug Resistant Epilepsy","Ketogenic Dieting",[54,55,56],"ketogenic diet","epilepsy","drug resistance","2024-01-23",{"date":59,"type":30},"2024-01-24",{"date":61,"type":30},"2024-01-15",{"date":63,"type":21},"2026-06",{"name":36,"class":37},1,""]