[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657797":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":49,"studyPopulation":49,"armGroups":58,"interventions":71,"overallOfficials":79,"centralContacts":84,"locations":94,"responsibleParty":116,"collaborators":49,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":49,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":49,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":49,"overallStatus":137,"whyStopped":49,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"BioGaia AB","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Changes in Social Responsiveness Scale-2 (SRS-2) score","Changes in the SRS-2 score in the L. reuteri group compared to the placebo group. The SRS-2 is a 65-item questionnaire, with higher scores indicating greater social impairment and severity of autism-related traits.","From baseline to end of study (6 months)",[14,17,20,24,27],{"measure":15,"description":16,"timeFrame":12},"Change in Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) Calibrated Severity Score (CSS) for Social Affect","Change in ADOS-2 CSS for Social Affect in the L. reuteri group compared to the placebo group.\n\nADOS-2 is a semi-structured, standardized assessment that observes social interaction, communication, play, and restricted or repetitive behaviors across five modules tailored to age and language level. Higher scores indicate a higher level of autism-related behaviors.",{"measure":18,"description":19,"timeFrame":12},"Change in total Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) score","Change in total ADOS-2 score in the L. reuteri group compared to the placebo group.\n\nADOS-2 is a semi-structured, standardized assessment that observes social interaction, communication, play, and restricted or repetitive behaviors across five modules tailored to age and language level. Higher scores indicate a higher level of autism-related behaviors.",{"measure":21,"description":22,"timeFrame":23},"Change in GI symptoms","Change in GI symptoms, assessed by the 6 item Gastrointestinal Severity Index (6-GSI) in the L. reuteri group compared to the placebo group.\n\n6-GSI is a six item questionnaire with total score 0-12 with higher scores indicating worse outcome.","From baseline to end fo study (6 months)",{"measure":25,"description":26,"timeFrame":23},"Change in ABAS-2 score","Change in adaptive behaviour, assessed by the Adaptive Behavior Assessment System, Second Edition (ABAS-2) in the L. reuteri group compared to the placebo group.\n\nABAS-2 is a 4-point rating scale with the scoring system divided into skill area scores (range 1 to 19), domain scores (range 40 to 160) and general adaptive composite (40 to 150). A higher score indicates a better outcome.",{"measure":28,"description":29,"timeFrame":30},"Proportion of responders","Proportion of responders at 6 months, evaluating all assessments and questionnaires, in the L. reuteri group compared to the placebo group.","At 6 months",[32,35,38,42],{"measure":33,"description":34,"timeFrame":23},"Change in Family Quality of Life","Change in family Quality of Life (QoL), assessed by the Pediatric Quality of Life Inventory™ Family Impact Module (PedsQL™ Family Impact Module), in the L. reuteri group compared to the placebo group.\n\nThe range of the total score is 0-100 with a higher score indicating a better outcome.",{"measure":36,"description":37,"timeFrame":12},"Change in quality of sleep","Change in sleep quality, assessed by the Children's Sleep Habits Questionnaire, in the L. reuteri group compared to placebo.\n\nThe CSHQ is scored on 33 of 52 items, using a 1-3 scale, with total score range 33-99. A higher score indicates worse outcome and the cut-off of a total score of 41 or higher indicating potential sleep problems.",{"measure":39,"description":40,"timeFrame":41},"Impact of dietary habits","Impact of dietary habits, assessed by a Food Frequency Questionnaire (FFQ), on the gut microbiota profile and effect of the L. reuteri intervention.","At baseline and end of study (6 months)",{"measure":43,"description":44,"timeFrame":45},"Changes in gut microbiota structure and composition","Changes in the gut microbiota structure and composition and the effect of the L. reuteri intervention, assessed by metagenomic analysis of fecal samples","Baseline, 3 and 6 months",{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":49,"timePerspective":49,"maskingInfo":51},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":52,"maskingDescription":49,"whoMasked":53},"QUADRUPLE",[54,55,56,57],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[59,65],{"label":60,"type":61,"description":62,"interventionNames":63},"Probiotics","EXPERIMENTAL","Probiotic oil drops formulation. Administered once daily.",[64],"Dietary Supplement: Probiotics",{"label":66,"type":67,"description":68,"interventionNames":69},"Placebo","PLACEBO_COMPARATOR","Placebo oil drops formulation. Administered once daily.",[70],"Dietary Supplement: Placebo",[72,76],{"type":73,"name":60,"description":74,"armGroupLabels":75,"otherNames":49},"DIETARY_SUPPLEMENT","Combination of L. reuteri strains.",[60],{"type":73,"name":66,"description":77,"armGroupLabels":78,"otherNames":49},"Placebo identical to the active product, except the addition of probiotics.",[66],[80],{"name":81,"affiliation":82,"role":83},"Romina L Squartini, MD","Sanatorio Maipú","PRINCIPAL_INVESTIGATOR",[85,90],{"name":86,"role":87,"phone":88,"phoneExt":49,"email":89},"Sanna H Nystrom, PhD","CONTACT","+46761483866","sny@biogaia.se",{"name":91,"role":87,"phone":92,"phoneExt":49,"email":93},"Anna Pauter, PhD","+46 76 328 04 77","anp@biogaia.se",[95],{"facility":82,"status":49,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"Mendoza","Maipú","M5515DUF","Argentina","AR",{"type":102,"coordinates":103},"Point",[104,105],-68.84582,-32.88946,{"lat":105,"lon":104},[108,111,115],{"name":81,"role":87,"phone":109,"phoneExt":49,"email":110},"+54 261 7539084","lrsquartini@gmail.com",{"name":112,"role":87,"phone":113,"phoneExt":49,"email":114},"Eugenia Yañez","+54 261 6594152","eyanezic@gmail.com",{"name":81,"role":83,"phone":49,"phoneExt":49,"email":49},{"type":117,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100657797","effect-of-limosilactobacillus-reuteri-on-social-deficits-in-children-with-autistic-spectrum-disorder-100657797",false,"NCT07845253","Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder","Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder: a Double-blind, Randomized, Placebo-controlled, Parallel-group Clinical Study","Inclusion Criteria:\n\n* Boys or girls aged between 4 to 12 years at screening.\n* ASD diagnosis confirmed by a qualified clinician according to DMS-5 criteria, M-CHAT used as a screening tool.\n* Parents\u002Fcaregivers\u002Flegal guardians are ≥18 years.\n* Readiness and the opportunity for parents\u002Fcaregivers\u002Flegal guardians to fill out a study diary, questionnaires, and report regularly during the intervention period.\n* Parents\u002Fcaregivers\u002Flegal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.\n* Parents\u002Fcaregivers\u002Flegal guardians willing and able to give informed consent for their and their child's participation in the study.\n\nExclusion Criteria:\n\n* Neurological syndromes that could explain autism disorders.\n* Organic gastrointestinal disorders (e.g. IBD, peptic ulcers and cancer). Celiac disease is accepted\n* Any other severe clinically relevant disease or disorder which may affect the participation in the study, based on the investigator's judgement.\n* Allergy or intolerance to one of the excipients of the probiotic product.\n* Children with reported exposure to probiotic supplements in the 15 days prior to Screening Visit (V1).\n* Children with reported exposure to oral and\u002For systemic antibiotics in the 7 days prior to Screening Visit (V1).\n* Children with reported exposure to proton pump inhibitors in the 7 days prior to Screening Visit (V1).\n* Participation in other interventional clinical study.","ALL","4 Years","12 Years",{"count":129,"type":130},200,"ESTIMATED","INTERVENTIONAL",[133],"NA","This is a double-blind, randomized, placebo-controlled, parallel-group study in children with Autism Spectrum Disorder (ASD) to evaluate the effect of a probiotic product on the ASD symptoms.",[136],"Autism Spectrum Disorder","NOT_YET_RECRUITING","2026-09-28",{"date":140,"type":141},"2026-09-30","ACTUAL",{"date":143,"type":130},"2026-10-15",{"date":145,"type":130},"2027-10-31",{"name":5,"class":6},1]