[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562773":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":37,"locations":46,"responsibleParty":67,"collaborators":69,"id":72,"slug":12,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":12,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":12,"enrollmentInfo":80,"targetDuration":12,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":49,"whyStopped":12,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"The University of Texas Medical Branch, Galveston","OTHER",[8,13,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Community Controls","NO_INTERVENTION","Community Control subjects will not receive intervention.",null,{"label":14,"type":10,"description":15,"interventionNames":12},"Brain Injury Patients - no intervention","Brain injury patients receiving residential standard of care post-acute neurorehabilitation.",{"label":17,"type":18,"description":19,"interventionNames":20},"Brain Injury Patients - inulin intervention","ACTIVE_COMPARATOR","Brain injury patients receiving residential standard of care post-acute neurorehabilitation plus 42 days of daily oral inulin supplementation (4g 2x daily).",[21],"Dietary Supplement: Inulin",[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":12},"DIETARY_SUPPLEMENT","Inulin","Inulin, 4g twice daily for 42 days",[17],[29,33],{"name":30,"affiliation":31,"role":32},"Randall Urban, MD","University of Texas","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":36},"Ana Durand, MD","Moody Neurorehabilitation Institute","STUDY_DIRECTOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":12,"email":42},"Kate Randolph, BS","CONTACT","409-772-8126","kmrandol@utmb.edu",{"name":44,"role":40,"phone":41,"phoneExt":12,"email":45},"Christopher Danesi, MS","cpdanesi@utmb.edu",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University of Texas Medical Branch","RECRUITING","Galveston","Texas","77555","United States",{"type":55,"coordinates":56},"Point",[57,58],-94.7977,29.30135,{"lat":58,"lon":57},[61,63,65],{"name":62,"role":40,"phone":41,"phoneExt":12,"email":42},"Kate M Randolph, BS",{"name":64,"role":40,"phone":41,"phoneExt":12,"email":45},"Christopher P Danesi, MS",{"name":66,"role":32,"phone":12,"phoneExt":12,"email":12},"Randall J Urban, MD",{"type":68,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[70],{"name":35,"class":71},"UNKNOWN","100562773",false,"NCT06607523","The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms","Brain Injury Patients\n\nInclusion\n\n* Ages 18 and above\n* Admitted to Moody Neurorehabilitation Institute for care\n* Less than 6 months post-injury\n* English speaking\n* Must be able to eat and drink by mouth\n* Willing and able to comply with study procedures\n* Willing and able to provide consent (with LAR if needed)\n\nExclusion\n\n* Significant heart, liver, kidney, blood or respiratory disease\n* HIV, Hepatitis B or Hepatitis C\n* Pregnancy or becoming pregnant during the study\n* History of inflammatory bowel disease\n* History of celiac disease\n* Active diverticular disease\n* Known allergy to study agent\n* Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation\n\nCommunity Control Subjects\n\nInclusion\n\n* Ages 18 and above\n* Have a family member who is admitted to Moody Neurorehabilitation Institute for care OR is working at Moody Neurorehabilitation Institute\n* English speaking\n* Willing and able to comply with study procedures\n* Willing and able to provide consent\n* FACs score ≤ 50\n\nExclusion\n\n* Trauma to head in last 6 months\n* Stroke in last 6 months\n* Significant heart, liver, kidney, blood or respiratory disease\n* HIV, Hepatitis B or Hepatitis C\n* Pregnancy or becoming pregnant during the study\n* History of inflammatory bowel disease\n* History of celiac disease\n* Active diverticular disease\n* Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation",true,"ALL","18 Years",{"count":81,"type":82},130,"ESTIMATED","INTERVENTIONAL",[85],"NA","The aim of this study is to characterize the microbiome of patients undergoing post-acute residential neurorehabilitation compared to community controls and to determine if a dietary fiber, Inulin, can create a shift in the microbiome leading to changes in fatigue and cognition.",[88],"Brain Injuries",[90,91,92,93],"Brain Injury","Neurorehabilitation","Fatigue","Cognition","2025-12-12",{"date":96,"type":97},"2025-12-19","ACTUAL",{"date":99,"type":97},"2025-03-06",{"date":101,"type":82},"2028-10-01",{"name":5,"class":6},1]