[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infant-colic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infant-colic":28},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100594269","effect-of-a-dietary-supplement-vs-low-dosage-product-on-infant-gastrointestinal-discomfort-and-colics-100594269",false,"NCT07017244","Effect of a Dietary Supplement vs Low-dosage Product on Infant Gastrointestinal Discomfort and Colics","Randomized Double-blind Monocentric Clinical Trial on the Effect of a Dietary Supplement vs Low-dosage Product on Reduction of Infant Gastrointestinal Discomfort and Colics","DISIC","Inclusion Criteria:\n\n* Children Age: 0-9 months Infant colics diagnosed with FLACC (Face, Legs, Activity, Cry, Consolability - preverbal patient pain scale) and G4 Infant Colic Rome IV criteria\n\nExclusion Criteria:\n\n* infants suffering from acute or chronic diseases, such as chronic lung disease; diarrhea underlying specific diseases or developmental disorders confirmed by a pediatrician\n* infants participating in other clinical studies\n* age ≥ 9 months\n* neurological diseases\n* suspected or confirmed food allergy to the ingredients of the products under study\n* gastroesophageal reflux disease\n* use of antibiotics 1-2 weeks before enrolment\n* use of gastric acidity inhibitors at any time before enrolment\n* fever and\u002For infectious diseases at any time before enrolment\n* current systemic infections\n* history of congenital infections","ALL","0 Months","9 Months",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to verify whether a food supplement is effective in treating infantile colic of infants aged between 21 days and 9 months and the colonization ability of the gut microbiota by measuring faecal relative abundance of the gut microbiota probiotic treatment species.\n\nThe main outcomes are: - the mean number of crying episodes and the sleep duration - Relative abundance of the gut microbiota probiotic treatment species.",[28,29],"Infant Colic","Gut Microbiota","NOT_YET_RECRUITING","2025-06-11",{"date":33,"type":34},"2025-06-12","ACTUAL",{"date":36,"type":22},"2025-06-15",{"date":38,"type":22},"2025-12-15",{"name":40,"class":41},"Azienda Ospedaliera Universitaria Policlinico \"G. Martino\"","OTHER"]