[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571480":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":28,"locations":34,"responsibleParty":68,"collaborators":25,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":25,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":25,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":97,"whyStopped":25,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Roma La Sapienza","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pentabiocel","EXPERIMENTAL","Children with IBS who received probiotics once a day for 12 weeks.\n\nEvery sachet contains:\n\n* Lactobacillus casei LMG 101\u002F37P-17504 (5Å109 CFU\u002Fsachet)\n* Lactobacillus plantarum CECT 4528 (5Å109 CFU\u002Fsachet)\n* Bifidobacterium animalis subsp. lactis Bi1 LMG P- 17502 (10Å109 CFU\u002Fsachet)\n* Bifidobacterium breve Bbr8 LMG P-17501 (10Å109 CFU\u002Fsachet)\n* Bifidobacterium breve Bl10 LMG P-17500 (10Å\\~109 CFU\u002Fsachet)",[13],"Drug: Pentabiocel",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Children with irritative bowel sindrome who received placebo once a day for 12 weeks",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","This is a randomized, double-blind, placebo-controlled, multicenter clinical trial aimed at recruiting 56 pediatric patients with IBS.\n\nThe activities will be divided into the following phases:\n\n1. Patient Enrollment Phase: eligible patients will meet the diagnostic criteria for IBS, as defined by internationally recognized guidelines. Informed consent will be obtained from the legal guardians of the participants before their inclusion in the study.\n2. Randomization: the enrolled participants will be randomly assigned to one of two groups: the probiotic group or the placebo group.\n3. Treatment Phase: a 3-month treatment phase will be conducted with a mixture of 5 strains of lactic acid bacteria and bifidobacter.\n4. Follow-up Phase: this will be followed by a 4-week follow-up phase. Clinical data will be monitored throughout the study using validated questionnaires.",[9],null,{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":25,"email":33},"Giovanni Di Nardo, Professor, MD","CONTACT","+39 3397267637","giovanni.dinardo@uniroma1.it",[35,47,53,59],{"facility":36,"status":25,"city":37,"state":25,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":25},"Ospedale Fatebenefratelli e Oftalmico","Milan","20121","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],9.18951,45.46427,{"lat":45,"lon":44},{"facility":48,"status":25,"city":37,"state":25,"zip":49,"country":39,"countryCode":40,"cosmosGeoPoint":50,"geoPoint":52,"contacts":25},"Ospedale Macedonio Melloni","20129",{"type":42,"coordinates":51},[44,45],{"lat":45,"lon":44},{"facility":54,"status":25,"city":37,"state":25,"zip":55,"country":39,"countryCode":40,"cosmosGeoPoint":56,"geoPoint":58,"contacts":25},"Ospedale Sacco","20157",{"type":42,"coordinates":57},[44,45],{"lat":45,"lon":44},{"facility":60,"status":25,"city":61,"state":25,"zip":62,"country":39,"countryCode":40,"cosmosGeoPoint":63,"geoPoint":67,"contacts":25},"Azienda Ospedaliera Sant'Andrea","Rome","00189",{"type":42,"coordinates":64},[65,66],12.51133,41.89193,{"lat":66,"lon":65},{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Prof. Giovanni Di Nardo","Professor","100571480","pentabiocel-in-pediatric-ibs-100571480",false,"NCT06720805","Pentabiocel in Pediatric IBS","Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of a Multi-strain Probiotic in Pediatric Irritable Bowel Syndrome (PTB_IBS)","Inclusion Criteria:\n\n. IBS diagnosis (all subtypes) according to Rome IV criteria\n\n* 4 -17 years of age\n* endoscopy examination (with bioptic samples) negative for IBD or microscopic colitis\n* negative anti-transglutaminase antibodies\n* capability to follow the protocol\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Presence of chronic, chromosomal, or congenital anomalies, autoimmune diseases, metabolic diseases, or immunodeficiencies.\n* Patients with concomitant conditions that may cognitively impair their understanding of study instructions and their ability to provide informed consent.\n* Current use of non-steroidal anti-inflammatory drugs, corticosteroids, and mast cell stabilizers, use of topical or systemic antibiotics in the past month, continuous use of stimulant laxatives, major abdominal surgery, inflammatory bowel disease, infectious diarrhea, allergic diseases, and other organic or psychiatric disorders.\n* Patients with concomitant organic gastrointestinal diseases (inflammatory bowel disease, celiac disease, cancer) or a major illness such as diabetes or uncontrolled thyroid disease.\n* Patients with a history of intestinal surgery (excluding appendectomy or cholecystectomy).","ALL","4 Years","17 Years",{"count":83,"type":84},56,"ESTIMATED","INTERVENTIONAL",[87],"NA","Irritable Bowel Syndrome (IBS) is a common gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits, including diarrhea, constipation, or a combination of both. It is estimated to affect about 10-20% of the global population, with a higher prevalence among children and adolescents. The pathophysiology of IBS is multifactorial and involves alterations in the gut microbiota, visceral hypersensitivity, and abnormal gastrointestinal motility. Probiotics, defined as live microorganisms that provide health benefits when administered in adequate amounts, have emerged as a potential therapeutic option for IBS due to their ability to modulate the gut microbiota and exert anti-inflammatory and immunomodulatory effects.\n\nSeveral studies have shown the beneficial effects of probiotics in adult IBS patients; however, few studies have been conducted in the pediatric population.\n\nThus, the investigators designed a randomized, double-blind, placebo-controlled, parallel-arm study evaluating the efficacy and safety of a 12-week probiotic treatment with a blend of 5 strains of lactic acid bacteria and bifidobacteria in pediatric patients with Irritative Bowel syndrome.",[90,91],"Irritable Bowel Syndrome (IBS)","Pediatrics",[90,93,94,95,96,91],"Bifidobacterium","Visceral hypersensitivity","microbiome","Lactobacillus","NOT_YET_RECRUITING","2024-12-02",{"date":100,"type":101},"2024-12-06","ACTUAL",{"date":103,"type":84},"2024-12-01",{"date":105,"type":84},"2025-12-31",{"name":5,"class":6},4]