[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543156":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":33,"responsibleParty":50,"collaborators":11,"id":52,"slug":11,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":11,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":11,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"ProbiSearch SL","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotic","ACTIVE_COMPARATOR",null,[13],"Dietary Supplement: Probiotic",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Dietary Supplement: Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DIETARY_SUPPLEMENT","1 dose of the probiotic every 24 hours, for 6-months.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"1 dose of the placebo every 24 hours, for 6-months.",[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Susana Manzano Jiménez, PhD","CONTACT","+34 918035179","susana.manzano@probisearch.com",[34],{"facility":35,"status":36,"city":37,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Hospital Universitario Infantil Niño Jesús","RECRUITING","Madrid","Spain","ES",{"type":41,"coordinates":42},"Point",[43,44],-3.70256,40.4165,{"lat":44,"lon":43},[47],{"name":48,"role":30,"phone":49,"phoneExt":11,"email":32},"Silvia Gutierrez, MD","+34918035179",{"type":51,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100543156",false,"NCT06352203","Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients","Randomized, Double-blind, Placebo-controlled Study to Evaluate the Modulating Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients With Neurodevelopmental Disorders.","Inclusion Criteria:\n\n* Children aged 3 to 7 years old.\n* Diagnosed with autism spectrum disorder, according to the clinical criteria of the \"Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)\" and who meet criteria for ASD according to the ADOS-2 classification.\n* Presenting one or more gastrointestinal symptoms (constipation, diarrhoea, abnormal stools, painful defecation, abdominal pain, reflux, bloating, flatulence).\n* Written informed consent signed by the parent or legal guardian with express or tacit consent of the other parent.\n\nExclusion Criteria:\n\n* With intake of antibiotics in the last month.\n* With intake of probiotics in the last two weeks.\n* Diagnosed with short bowel syndrome or has undergone relevant surgery on the gastrointestinal tract.\n* Exhibiting a defect in the intestinal epithelial barrier (e.g. inflammatory bowel disease (IBD)).\n* Diagnosed with endocrinological diseases such as diabetes mellitus, hypo- and hyperthyroidism, Cushing's disease, Addison's disease, etc.\n* Having heart failure and a cardiac medical history (e.g. artificial heart valve, medical history of infective endocarditis, rheumatic fever, or cardiac malformation).\n* Congenital or acquired immunodeficiency.\n* Immunocompromised (e.g., cancer and\u002For transplant patients taking certain immunosuppressive drugs, patients with inherited diseases that affect or may affect the immune system).\n* Uncertainty on the part of the investigator about the willingness or ability of the minor's parents or legal guardian to comply with the requirements of the protocol.\n* With oral hyper sensitivity impairments that prevent the uptake of the study product.","ALL","3 Years","7 Years",{"count":62,"type":63},60,"ESTIMATED","INTERVENTIONAL",[66],"NA","Numerous studies have described an altered gut microbiota composition (dysbiosis) in patients with neurodevelopmental disorders that can be correlated with their symptoms, especially gastrointestinal symptoms.\n\nAn interventional, randomised, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic supplement on the microbiota composition of children aged 3-7 years with neurodevelopmental issues.\n\nThe duration of the study will be of 6 months approximately, including 6 months of product intake.\n\nParticipants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group.",[69],"Neurodevelopmental Disorders","2026-02-24",{"date":72,"type":73},"2026-02-25","ACTUAL",{"date":75,"type":73},"2024-04-12",{"date":77,"type":63},"2026-12",{"name":5,"class":6},1]