protocolSection identificationModule nctId: NCT06290258, orgStudyIdInfo id: 202202143A0, briefTitle: Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the efficacy of fecal microbiota transplantation on the gastrointestinal symptoms, autistic symptoms and emotional behavior symptoms of patients with autism spectrum disorder, and investigate the relations between the brain-gut axis, cytokines and autism spectrum disorder. Fecal microbiota transplantation have the potentials to improve intestinal microbiota composition, regulate immunity, and then improve gastrointestinal symptoms, autistic symptoms, emotional behavior symptoms and sleep of children with autism spectrum disorder. Early intervention at school-age may even benefit development, improve cognition and prognosis., conditionsModule conditions: Autism Spectrum Disorder, conditions: Gastrointestinal Diseases, conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Fecal microbiota transplantation, outcomesModule primaryOutcomes measure: Changes of gastrointestinal symptoms of patients with ASD after FMT, primaryOutcomes measure: Changes of autistic symptoms of patients with ASD after FMT, secondaryOutcomes measure: Changes of the diversity of intestinal microbiota of patients with ASD after FMT, secondaryOutcomes measure: Changes of cytokine levels of patients with ASD after FMT, secondaryOutcomes measure: Changes of repetitive behavior symptoms of patients with ASD after FMT, secondaryOutcomes measure: Changes of autistic behavior symptoms of patients with ASD after FMT, secondaryOutcomes measure: Changes of emotion and behavior symptoms of patients with ASD after FMT, secondaryOutcomes measure: Changes of inattention and hyperactivity of patients with ASD after FMT, secondaryOutcomes measure: Changes of quality of life of patients with ASD after FMT, otherOutcomes measure: Changes of objective sleep of patients with ASD after FMT by actigraphy recording, otherOutcomes measure: Changes of subjective sleep of patients with ASD after FMT, otherOutcomes measure: Changes of intelligence of patients with ASD after FMT, otherOutcomes measure: Changes of attention and impulse control of patients with ASD after FMT, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 30 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Wei-Chih Chin, city: Taoyuan city, zip: 333423, country: Taiwan, contacts name: Wei-Chih Chin, role: CONTACT, phone: +886 3 3281200, phoneExt: 3836, email: auaug0327@cgmh.org.tw, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False