protocolSection identificationModule nctId: NCT06279858, orgStudyIdInfo id: 1-2024, briefTitle: Probiotic Intervention for Microbiome Modifications and Clinical Improvements in Fragile X Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Specila hospital for cerebral palsy and developmental neurology, class: OTHER, collaborators name: FRAXA Research Foundation, descriptionModule briefSummary: The primary objective of this clinical trial is to evaluate efficacy of probiotic mixture which contains Lactobacillus casei, Lactobacillus salivarius and Bifidobacterium breve, in children with Fragile X aged 3-18 years. Specifically, links between microbiome modifications by probiotic mixture and behavioral manifestations and brain processing (eye tracker, EEG analysis) will be assessed. Exploratory objects of this trial are analyses of microbiome composition and assessment of its alterations and modifications (by probiotic mixture) that may lead to clinical improvement and prediction which patients with FXS may be likely to benefit from probiotics treatment.This is open label trial without masking, where each participant receives probiotic for 3 months (12 weeks). It will be single group assignment. The study plans to enroll 15 participants with FXS, aged 3-18 years, both sexes, during 1-year period and complete all study-related activities by January 2025. During the 3-month study period, subjects will attend three visits (screening/baseline, 6-week, and 3-month visits) to the Fragile X Clinic at the Special Hospital for Cerebral Palsy and Developmental Neurology, Belgrade, Serbia. The primary outcome measureswill be Vineland Adaptive Behavior Scales-Third Edition (VABS-III) and eye tracking measures (social gaze and pupillometry). Exploratory endpoint will be microbiome analyses. Secondary outcome measures will be: CGI-S and CGI-I scores, ABC-CFX score, quality of life, sleep habits and EEG analyses., conditionsModule conditions: Fragile X Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is open label trial without masking, where each participant receives probiotic for 3 months (12 weeks). It will be single group assignment. In this approach, participants act as their own controls by measuring the microbiome and other parameters before and after taking the probiotics. This design was chosen because individual's microbiome is highly personalized. Even within a family, individuals can have distinct microbiomes. The unique composition of an individual's microbiome can have implications for the effectiveness of probiotics. Thus, changes in analyses and scores between baseline and 3-month study period will be assessed for everyone. Specifically, microbiome modifications that may be associated with changes in behavior and brain processing will be examined., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Probiotics, outcomesModule primaryOutcomes measure: 1. Vineland Adaptive Behavior Scales-Third Edition (VABS-III), primaryOutcomes measure: Eye tracking, secondaryOutcomes measure: Clinical Global Impression Scales of Severity (CGI-S) and Improvement (CGI-I) -, secondaryOutcomes measure: The Aberrant Behavior Checklist - Community Edition (ABC-C), scored using the FXS-specific factoring system (ABC-CFX), secondaryOutcomes measure: Pediatric Quality of Life Questionnaire (PedsQL) Parent Proxy, secondaryOutcomes measure: Child Sleep Habits Questionnaire (CSHQ), secondaryOutcomes measure: EEG analyses, otherOutcomes measure: Microbiome analyses, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Special Hospital for Cerebral Palsy and Developmental Neurology, status: RECRUITING, city: Belgrade, zip: 11000, country: Serbia, contacts name: Dragana Protic, Prof., role: CONTACT, phone: +381640667466, email: dragana.protic@sbcprn.com, contacts name: Sanja Dimitrijevic, PhD, role: CONTACT, phone: +381640667466, email: sanja.dimitrijevic@sbcprn.com, geoPoint lat: 44.80401, lon: 20.46513, hasResults: False