[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634208":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":26,"responsibleParty":39,"collaborators":43,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":26,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":26,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":26,"overallStatus":65,"whyStopped":26,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":26},{"fullName":5,"class":6},"Liaquat University of Medical & Health Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bifidobacterium longum W11 (Bowell®) + Colopectin + (Colopectin®)","EXPERIMENTAL","Participants will receive co-supplementation with Bifidobacterium longum W11 (Bowell®) and Colopectin (Colopectin®) administered once daily between meals in the afternoon for 4 weeks, followed by 4 weeks of follow-up after treatment discontinuation.",[13],"Dietary Supplement: Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo (corn starch) formulated in sachets, administered once daily between meals in the afternoon for 4 weeks, followed by 4 weeks of follow-up after treatment discontinuation.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®)","Combination of probiotic (Bifidobacterium longum W11) and prebiotic components (Colopectin) administered in sachet form once daily between meals in the afternoon.",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Placebo composed of corn starch, matched in appearance and administration schedule to the active intervention.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Francesco Valitutti, MD, PhD","CONTACT","+39 392 232 2182","Francesco.valitutti@unipg.it",{"name":37,"role":33,"phone":26,"phoneExt":26,"email":38},"Dr Amjad Khan, DPhil","amjadkhan@lumhs.edu.pk",{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Dr. Amjad Khan","Professor",[44],{"name":45,"class":6},"Università degli Studi dell'Insubria","100634208","co-supplementation-with-bifidobacterium-longum-w11-and-colopectin-for-maintenance-therapy-in-children-with-functional-constipation-100634208",false,"NCT07536698","Co-supplementation With Bifidobacterium Longum W11 and Colopectin for Maintenance Therapy in Children With Functional Constipation","Efficacy of Co-supplementation With Bifidobacterium Longum W11 and Colopectin in the Maintenance Therapy of Children With Functional Constipation: A Randomized Double-Blind Placebo-Controlled Trial","Inclusion Criteria:\n\n* Children aged 2 to 6 years\n* Diagnosis of functional constipation\n* Receiving maintenance therapy with macrogol for at least 3 months\n* Candidates for weaning from macrogol therapy\n\nExclusion Criteria:\n\n* Children with intestinal meteorism or flatulence\n* Children diagnosed with organic constipation\n* History of previous abdominal surgery\n* Children with frailty or disabilities\n* Presence of other organ diseases or syndromes","ALL","2 Years","6 Years",{"count":57,"type":58},100,"ESTIMATED","INTERVENTIONAL",[61],"NA","Functional constipation is a common condition in children and often requires prolonged maintenance treatment with macrogol. This randomized, double-blind, placebo-controlled trial will evaluate whether co-supplementation with Bifidobacterium longum W11 and Colopectin can support maintenance therapy in children with functional constipation who are receiving macrogol and are candidates for weaning. Participants aged 2 to 6 years will be randomized to receive either the active supplementation or placebo once daily for 4 weeks, followed by 4 weeks of follow-up after treatment discontinuation. The study will assess persistence of constipation after macrogol discontinuation, as well as stool consistency, distress during evacuation, soiling episodes, and treatment compliance.",[64],"Functional Constipation","NOT_YET_RECRUITING","2026-04-15",{"date":68,"type":69},"2026-04-17","ACTUAL",{"date":71,"type":58},"2026-04-20",{"date":73,"type":58},"2027-05-17",{"name":5,"class":6}]