[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651104":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":63,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Roma La Sapienza","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Probiotic Group (Bifipral®)","EXPERIMENTAL","Non-breastfed infants receiving oral drops containing a probiotic blend of Bifidobacterium bifidum BFP19® and Bifidobacterium bifidum BFP29® (Bifipral®) daily for 8 weeks.",[13],"Dietary Supplement: Bifidobacterium bifidum BFP19® and BFP29® (Bifipral®)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Control Group","PLACEBO_COMPARATOR","Non-breastfed infants receiving oral drops of an indistinguishable placebo daily for 8 weeks.",[19],"Dietary Supplement: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Bifidobacterium bifidum BFP19® and BFP29® (Bifipral®)","Oral drops containing a combination of Bifidobacterium bifidum BFP19® and Bifidobacterium bifidum BFP29®. Administered at a dose of 5 drops once daily (providing a total of 4 x 10⁹ CFU\u002Fday, 2 x 10⁹ CFU per strain), preferably in the morning before feeding, for 8 weeks.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Matching placebo oral drops, indistinguishable from the active intervention in packaging, color, odor, taste, consistency, and labeling. Administered at a dose of 5 drops once daily, preferably in the morning before feeding, for 8 weeks.",[15],[32],{"name":33,"affiliation":34,"role":35},"Giovanni Di Nardo, Professor","UOC Pediatrics, AOU Sant'Andrea, Rome \u002F Sapienza University of Rome","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","0633775870","giovanni.dinardo@uniroma1.it",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Maurizio Mennini, MD","+39 0633775780","dott.mauriziomennini@gmail.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"AOU Sant'Andrea","RECRUITING","Roma","RM","00189","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],11.10642,44.99364,{"lat":58,"lon":57},[61],{"name":62,"role":38,"phone":39,"phoneExt":26,"email":44},"Maurizio Mennini, Doctor",{"type":35,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Prof. Giovanni Di Nardo","Professor","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":78,"type":79},64,"ESTIMATED","INTERVENTIONAL",[82],"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.",[85,86],"Infant Colic","Atopic Dermatitis",[88,89,90,91,92,93],"Bifidobacterium bifidum","Infant colic","Atopic dermatitis","Probiotics","Gut microbiota","Randomized Controlled Trial","2026-08-04",{"date":96,"type":97},"2026-08-10","ACTUAL",{"date":99,"type":97},"2026-07-01",{"date":101,"type":79},"2028-09-01",{"name":5,"class":6},1]