[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649866":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":81,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Istituto Giannina Gaslini","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Gabapral® followed by Placebo","EXPERIMENTAL","Participants assigned to this sequence will receive Gabapral® (Bifidobacterium adolescentis PRL2019) as an oral supplement once daily for 12 weeks. This treatment period will be followed by a 6-week washout period without study treatment. Participants will then receive matching placebo once daily for 12 weeks. Treatments will be administered under double-blind conditions.",[13,14],"Dietary Supplement: Bifidobacterium adolescentis PRL2019","Dietary Supplement: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Placebo followed by Gabapral®","Participants assigned to this sequence will receive matching placebo as an oral supplement once daily for 12 weeks, followed by a 6-week washout period without study treatment. Participants will then receive Gabapral® (Bifidobacterium adolescentis PRL2019) once daily for 12 weeks. Treatments will be administered under double-blind conditions.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Bifidobacterium adolescentis PRL2019","Gabapral® is an oral food supplement containing Bifidobacterium adolescentis PRL2019, provided as single-dose oral sticks containing 20 × 10\\^9 colony-forming units (CFU). Participants will receive one oral stick once daily for a 12-week treatment period according to the assigned treatment sequence. The product is gluten- and lactose-free.",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Matching placebo provided as an oral supplement stick, identical to Gabapral® in appearance, taste, texture, weight, and packaging. The placebo does not contain Bifidobacterium adolescentis PRL2019 or other active microorganisms. Participants will receive one oral stick once daily during the assigned 12-week treatment period.",[9,16],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Clara Malattia","CONTACT","010 5636 2843","claramalattia@gaslini.org",[37],{"facility":38,"status":25,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"IRCCS Giannina Gaslini","Genova","16147","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],11.87211,45.21604,{"lat":47,"lon":46},[50],{"name":32,"role":33,"phone":51,"phoneExt":25,"email":35},"01056362843",{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100649866","prl2019-in-the-treatment-of-juvenile-fibromyalgia-100649866",false,"NCT07738926","PRL2019 in the Treatment of Juvenile Fibromyalgia","A Prospective, Randomised, Controlled Crossover Study on the Effectiveness of Bifidobacterium Adolescentis PRL2019 in the Treatment of Juvenile Fibromyalgia","IGG-microbiota","Inclusion Criteria:\n\n* Patients aged between 9 and 25 years;\n* Written informed consent to participate in the study obtained prior to the start of the study from the patient or both parents\u002Flegal guardians of the patient if a minor, and the assent of the minor;\n* Diagnosis of JFS according to the 2010 American College of Rheumatology (ACR) criteria 15, with disease onset before 18 years of age;\n* Willingness to comply with follow-up visits and provide biological samples (blood and stool) according to the schedule defined in the protocol.\n\nExclusion Criteria:\n\n* any conditions that may affect the ability to complete informed consent;\n* denial of the informed consent;\n* presence of concomitant organic GI diseases, such as inflammatory bowel disease, celiac disease, eosinophilic or autoimmune gastroenteropathies, or history of major abdominal surgery;\n* acute infection at the time of recruitment;\n* antibiotic treatment within 3 months prior to recruitment;\n* use of any prebiotic, probiotic, or postbiotic in the previous 2 months before enrolment;\n* significant eating disorders, including diagnosed eating behaviour disorders.","ALL","9 Years","25 Years",{"count":66,"type":67},30,"ESTIMATED","INTERVENTIONAL",[70],"NA","Juvenile Fibromyalgia Syndrome (JFS) is a chronic condition affecting children and adolescents, characterised by widespread musculoskeletal pain and a significant impact on daily life and quality of life. Gastrointestinal symptoms and changes in gut microbiota have been reported in patients with fibromyalgia, suggesting a possible role of the gut-immune system interaction in the disease.\n\nThis study aims to investigate whether Gabapral®, a food supplement containing the probiotic strain Bifidobacterium adolescentis PRL2019, may help reduce pain symptoms and improve clinical outcomes in paediatric patients with JFS.\n\nThe hypothesis of this study is that modulation of the gut microbiota with Gabapral® may contribute to improvement of symptoms related to Juvenile Fibromyalgia Syndrome.",[73,74],"Fibromyalgia","Fibromyalgia Syndrome",[76,77,78,79,80],"Juvenile Fibromyalgia Syndrome","Probiotics","Gut microbiota","Microbiome modulation","Chronic musculoskeletal pain","NOT_YET_RECRUITING","2026-07-27",{"date":84,"type":85},"2026-07-31","ACTUAL",{"date":87,"type":67},"2026-08-01",{"date":89,"type":67},"2026-09-30",{"name":5,"class":6},1]