[{"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,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100651104","use-of-bifidobacterium-bifidum-in-formula-fed-infants-with-colic-with-or-without-atopic-dermatitis-100651104",false,"NCT07754968","Use of Bifidobacterium Bifidum in Formula-Fed Infants With Colic, With or Without Atopic Dermatitis","Efficacy of Bifidobacterium Bifidum on Symptoms of Infant Colic and Atopic Dermatitis: a Randomized Controlled Trial.","Inclusion Criteria:\n\n* Non-breastfed infants aged ≤ 5 months diagnosed with infant colic according to Rome IV criteria, with or without atopic dermatitis.\n* Written informed consent from parents or legal guardians.\n\nExclusion Criteria:\n\n* Age \\> 5 months.\n* Exclusive breastfeeding or mixed feeding.\n* Absence of infant colic diagnosis.\n* Presence of chronic diseases, neoplasms, immunodeficiencies, chronic infections, autoimmune diseases, IBD, celiac disease, genetic-metabolic disorders, cystic fibrosis or other chronic pulmonary diseases, cardiovascular\u002Frespiratory\u002FGI malformations, neuropsychiatric disorders, neurological conditions, or vegetarian\u002Fvegan diet.",true,"ALL","1 Week","5 Months",{"count":21,"type":22},64,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to evaluate whether daily probiotic supplementation with Bifidobacterium bifidum (Bifipral® drops) can reduce crying time in formula-fed infants aged 5 months or younger diagnosed with infant colic (according to Rome IV criteria), with or without concomitant atopic dermatitis.\n\nThe main questions it aims to answer are:\n\n* Does daily administration of B. bifidum for 8 weeks achieve at least a 50% reduction in average daily crying duration compared to placebo?\n* Does B. bifidum supplementation improve secondary outcomes, including crying frequency, sleep quality, bowel movement frequency, stool consistency, fecal microbiota composition, short-chain fatty acid (SCFA) levels, and SCORAD score in infants with atopic dermatitis? Researchers will compare formula-fed infants receiving Bifipral® drops (containing B. bifidum strains BFP19® and BFP29®) to a comparison group receiving an indistinguishable placebo to see if the probiotic safely improves colic symptoms and gut microbiota balance.\n\nParticipants will be asked to:\n\n* Complete a 7-day observational run-in period to confirm eligibility and record baseline symptoms in a daily diary.\n* Administer 5 drops daily of the study product (probiotic or placebo) for 8 weeks.\n* Complete daily diaries tracking crying duration\u002Ffrequency, sleep parameters, and bowel habits.\n* Attend 3 clinical visits (Baseline, Week 8, and a Safety Follow-up 2-4 weeks post-treatment).\n* Provide fecal samples at Baseline (Visit 1) and Week 8 (Visit 2) for microbiota profiling and SCFA analysis.",[28,29],"Infant Colic","Atopic Dermatitis",[31,32,33,34,35,36],"Bifidobacterium bifidum","Infant colic","Atopic dermatitis","Probiotics","Gut microbiota","Randomized Controlled Trial","RECRUITING","2026-08-04",{"date":40,"type":41},"2026-08-10","ACTUAL",{"date":43,"type":41},"2026-07-01",{"date":45,"type":22},"2028-09-01",{"name":47,"class":48},"University of Roma La Sapienza","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":49},"100594269","effect-of-a-dietary-supplement-vs-low-dosage-product-on-infant-gastrointestinal-discomfort-and-colics-100594269","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","0 Months","9 Months",{"count":61,"type":22},150,[25],"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.",[28,65],"Gut Microbiota","NOT_YET_RECRUITING","2025-06-11",{"date":69,"type":41},"2025-06-12",{"date":71,"type":22},"2025-06-15",{"date":73,"type":22},"2025-12-15",{"name":75,"class":48},"Azienda Ospedaliera Universitaria Policlinico \"G. Martino\""]