[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601036":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":47,"collaborators":49,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":81,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Felictia Arm","EXPERIMENTAL","FMT",[13],"Drug: FMT Protocol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","FMT Protocol","FMT protocol Samples (urine, blood, stool) collection Psychological examination Pediatric quality of life Scale Bristol Stool form Scale",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Pierre ELLUL, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","0033140034635","pierre.ellul@aphp.fr",[31],{"facility":32,"status":20,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Robert Debré Hospital","Paris","Ap-hp \u002F DRCI","75019","France","FR",{"type":39,"coordinates":40},"Point",[41,42],2.3488,48.85341,{"lat":42,"lon":41},[45],{"name":23,"role":27,"phone":46,"phoneExt":20,"email":29},"0033140031635",{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[50,53,55],{"name":51,"class":52},"Fondation initiative autisme","UNKNOWN",{"name":54,"class":52},"Fondation Erie",{"name":56,"class":52},"Biocodex microbiota fondation","100601036","phase-2-open-label-phase-iia-trial-evaluating-the-effect-and-safety-of-transplantation-of-fecal-microbiota-in-children-with-autism-spectrum-disorders-and-gastrointestinal-symptoms-100601036",false,"NCT07105267","Open Label Phase IIa Trial Evaluating the Effect and Safety of Transplantation of Fecal Microbiota in Children With Autism Spectrum Disorders and Gastrointestinal Symptoms","A Proof of Concept Study : Open Label Phase IIa Trial Evaluating the Effect and Safety of Transplantation of Fecal Microbiota in Children With Autism Spectrum Disorders and Gastrointestinal Symptoms","FELICITA","Inclusion Criteria:\n\n* ASD diagnosis based on DSM-5 criteria\n* Gastrointestinal symptoms: at least a score of 5 on 1 of the 5 GSRS domains (diarrhea, abdominal pain, constipation, indigestion, reflux) for over a period of 1 year or more\n* Age between 36 and 72 months\n* Consent from all legal guardians\n* Social insurance affiliation\n\nExclusion Criteria:\n\n* Severe intellectual deficit (IQ\\\u003C30) or another uncontrolled comorbidity (e.g. epilepsy)\n* Recent change in ASD global care (cognitive behavioral therapy 6 weeks before inclusion)\n* Actual or past psychotropic medication\n* Contraindications to colon preparation (Picoprep®) and\u002For to Meopa)\n* Severe or uncontrolled gastrointestinal symptoms (e.g. urgent treatment needed)\n* Undernutrition (age related BMI \\\u003C 3rd percentile)\n* Inflammatory bowel disease\n* Exclusive diet (gluten- or sugar-free)\n* Rectal enema contraindication\n* Antibiotic or antifungal therapy 3 months before inclusion\n* Probiotics 2 months before inclusion or FMT 12 months before inclusion\n* Vancomycin or Picoprep® or Meopa (including excipients) known allergy or intolerance Experimental therapeutic trial participation 3 months before inclusion","ALL","36 Months","72 Months",{"count":69,"type":70},5,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","Autism Spectrum Disorders (ASD), affect approximately 1% of the general population and are characterized by impairments in social communication associated with repetitive\u002Fstereotyped behaviors. Approximately one-third of these patients display gastrointestinal (GI) symptoms, and a growing number of studies suggest abnormalities of gut microbiota in ASD. Gut microbiota and the brain interact through complex pathways. Preliminary evidence in adults with ASD suggests that modulation of the gut microbiota by probiotics and\u002For prebiotics and more recently by fecal microbiota transplantation could improve GI symptoms but also socio-communication deficit, with persistent improvement at year 2.",[76,77],"Autism Spectrum Disorder","Fecal Microbiota Transplantation (FMT)",[79,11,80],"Austim Spectrum Disorder","gastrointestinal symptom,","NOT_YET_RECRUITING","2025-07-29",{"date":84,"type":85},"2025-08-05","ACTUAL",{"date":87,"type":70},"2025-09-01",{"date":89,"type":70},"2027-04-01",{"name":5,"class":6},1]