[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594269":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":29,"responsibleParty":52,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":25,"overallStatus":75,"whyStopped":25,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Azienda Ospedaliera Universitaria Policlinico \"G. Martino\"","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Verum","EXPERIMENTAL","Partecipants received Enterobaby, a food supplement based on a mixture of Lactobacillus acidophilus DSM 25175, Lactobacillus reuteri DSM 24936, Matricaria chamomilla L. oleolite, extra-virgin olive oil in oral suspension",[13],"Dietary Supplement: Verum",{"label":15,"type":16,"description":17,"interventionNames":18},"Low-dosage product","ACTIVE_COMPARATOR","Partecipants received a food supplement based on a mixture of maltodextrine, Magnesium stearate and Sun flower oil and less than 0,1% of Lactobacillus acidophilus DSM 25175 and Lactobacillus reuteri DSM 24936, 1% of Matricaria chamomilla L. oleolite and extra-virgin olive oil in oral suspension",[19],"Dietary Supplement: Active comparator",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","1st cycle - 30 days continuous use Cycle 2 - 30-day washout",[9],null,{"type":22,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"Active comparator",[15],[30],{"facility":31,"status":25,"city":32,"state":25,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Gioacchino Calapai","Messina","98125","Italy","IT",{"type":37,"coordinates":38},"Point",[39,40],15.55256,38.19394,{"lat":40,"lon":39},[43,48],{"name":44,"role":45,"phone":46,"phoneExt":25,"email":47},"Gioacchino Calapai, MD","CONTACT","0902213646","gcalapai@unime.it",{"name":49,"role":45,"phone":50,"phoneExt":25,"email":51},"Carmen Mannucci, BSc","0902212697","cmannucci@unime.it",{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":66,"type":67},150,"ESTIMATED","INTERVENTIONAL",[70],"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.",[73,74],"Infant Colic","Gut Microbiota","NOT_YET_RECRUITING","2025-06-11",{"date":78,"type":79},"2025-06-12","ACTUAL",{"date":81,"type":67},"2025-06-15",{"date":83,"type":67},"2025-12-15",{"name":5,"class":6},1]