[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602600":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":56,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":84,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of Bari","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotic","EXPERIMENTAL","62 children will take the product under study based on One capsule\u002Fsachet containing L. Rhamnosus GG 1x10\\^10 CFU plus L. Plantarum 299V 1x10\\^10 CFU per day for 8 weeks",[13],"Dietary Supplement: Experimental arm: probiotic",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","62 children will take a carbohydrate-based control product (maltodextrin)",[19],"Dietary Supplement: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Experimental arm: probiotic","a dietary supplement containing L. Rhamnosus GG 1x1010 CFU plus L. Plantarum 299V. 1x1010 CFU",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Placebo (maltodextrine)",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Ruggiero Francavilla, Prof","CONTACT","00390805592063","rfrancavilla@gmail.com",{"name":37,"role":33,"phone":38,"phoneExt":26,"email":39},"fernanda Cristofori, MD","00393384176598","fernandacristofori@gmail.com",[41],{"facility":42,"status":26,"city":43,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Pediatria Trambusti","Bari","70100","Italy","IT",{"type":48,"coordinates":49},"Point",[50,51],16.86982,41.12066,{"lat":51,"lon":50},[54],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":55},"ruggiero.francavilla@uniba.it",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Ruggiero Francavilla","Professor","100602600","probiotic-mixture-l-rhamnosus-gg-and-l-plantarum-299v-in-pediatric-irritable-bowel-syndrome-100602600",false,"NCT07125625","Probiotic Mixture (L. Rhamnosus GG and L. Plantarum 299V) In Pediatric Irritable Bowel Syndrome","Randomized Double Blind Placebo Controlled Trial on a Probiotic Mixture (L. Rhamnosus GG Plus L. Plantarum 299V) in Pediatric Irritable Bowel Syndrome: Clinical Efficacy and Multiomics Approach","PRIME","Inclusion Criteria:\n\n* Children aged 4-18 years;\n* Irritable Bowel Syndrome according to Rome IV criteria\n* Average daily pain rate of at least 3 out of 10 VAS met during run-in period •-Written informed consent of parent's\u002Flegal tutor and verbal or written assent of the patient based on the minor's maturity\n\nExclusion Criteria:\n\n* Presence of other gastrointestinal diseases (inflammatory bowel disease, pancreatitis, chronic liver disease, eosinophilic esophagitis, peptic ulcer disease, celiac disease, pseudo-obstruction, small bowel bacterial overgrowth, or Hirschsprung's disease);\n* Significant chronic health condition requiring specialty care (e.g., lithiasis, ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic, hematopoietic, renal, endocrine, or metabolic diseases) that could potentially impact the child's ability to participate or confound the results of the study.\n* Primary or secondary immunodeficiency;\n* Malnutrition;\n* History of abdominal surgery in the past 3 months.;\n* Chronic or acute infectious diseases (viral, bacterial, parasitic) in progress;\n* Rome IV criteria diagnosis of functional constipation.\n* Use of probiotics\u002Fantibiotics within 4 weeks prior to enrolment;\n* Current pregnancy or breastfeeding;\n* Psychiatric conditions that reduce compliance with the protocol.","ALL","4 Years","18 Years",{"count":72,"type":73},124,"ESTIMATED","INTERVENTIONAL",[76],"NA","What is this study about? This clinical study aims to investigate whether a specific combination of probiotics-Lactobacillus rhamnosus GG and Lactobacillus plantarum 299V-can help children and adolescents with Irritable Bowel Syndrome (IBS). IBS is a common digestive condition in children, causing abdominal pain, bloating, and changes in bowel habits (either diarrhoea, constipation, or alternating between the two). These symptoms can seriously affect a child's daily life and wellbeing.\n\nThe study is coordinated by the University of Bari, in collaboration with the University of Udine, and led by Prof. Ruggiero Francavilla.\n\nWhy is this study being done? Although probiotics are increasingly used in IBS, solid scientific evidence in children is still limited. This study will assess whether the chosen probiotic mix improves symptoms, bowel habits, and quality of life in young people with IBS. It will also investigate how the probiotics affect gut bacteria (microbiota) and the chemicals produced by the body (metabolomics), to better understand how these changes might help relieve symptoms.\n\nWho can take part? Children and adolescents aged 4 to 18 years with a diagnosis of IBS (based on international Rome IV criteria) who experience abdominal pain on a daily basis.\n\nChildren with other significant medical conditions, recent surgery, or ongoing infections, as well as those taking antibiotics or other probiotics shortly before the study, cannot participate.\n\nHow does the study work? The study is a randomised, double-blind, placebo-controlled trial, meaning that some children will receive the probiotic drops, and others will receive placebo drops (which do not contain probiotics), and neither the participants nor the doctors will know who is receiving which treatment. This is the best way to test whether the probiotics really work.\n\nEach participant will be involved in the study for about 14 weeks, divided into:\n\nA 2-week \"run-in\" period to confirm eligibility.\n\nAn 8-week treatment period (probiotic or placebo).\n\nA 4-week follow-up.\n\nThe probiotics\u002Fplacebo are taken as 20 drops once daily for 8 weeks.\n\nThroughout the study, children and parents will be asked to keep a daily diary of abdominal pain and bowel habits, and to complete validated questionnaires on symptom severity and quality of life. Stool and urine samples will also be collected at different time points to analyse changes in gut bacteria and body metabolism.\n\nWhat are the aims of the study?\n\nPrimary aim:\n\nTo see whether the probiotics reduce abdominal pain by at least 30% compared to the start of the study.\n\nSecondary aims:\n\nTo check if bowel habits improve (stool consistency and frequency).\n\nTo assess improvements in quality of life.\n\nTo analyse whether the probiotics cause positive changes in gut bacteria and metabolic profiles.\n\nTo ensure that the treatment is safe and well-tolerated.\n\nWhat are the possible risks and benefits? The probiotic mixture used in this study has been studied in children before and is generally considered safe. The study includes careful monitoring for any side effects.\n\nParticipants may or may not experience an improvement in symptoms. However, the information gained from the study will help doctors better understand how probiotics work in IBS and may benefit future patients.\n\nWhat are participants' rights? Participation is voluntary, and families may withdraw their child from the study at any time, without affecting the child's medical care. The study has been approved by an independent ethics committee and complies with all European and Italian regulations regarding research in children.\n\nAll personal data and medical information will be treated confidentially and securely, in accordance with privacy laws.\n\nWhere is the study taking place? The study is being conducted at the Paediatric Gastroenterology Unit of the University of Bari Aldo Moro and the Paediatric Unit of the University of Udine. These centres are national referral centres for children with gastrointestinal problems.\n\nWho is funding and organising the study? The study is sponsored and conducted by the University of Bari. The probiotic and placebo products are provided by Dicofarm S.p.A., who also ensures that the placebo and probiotic products look and taste the same to maintain the study's blinding.",[79],"Irritable Bowel Syndrome (IBS)",[81,82,83],"food supplement","probiotics","irritable bowel syndrome","NOT_YET_RECRUITING","2025-08-13",{"date":87,"type":88},"2025-08-15","ACTUAL",{"date":90,"type":73},"2025-09-01",{"date":92,"type":73},"2027-06-30",{"name":5,"class":6},1]