[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05670288":3,"trial-entities:NCT05670288":195,"trial-summary:NCT05670288":199},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":33,"secondary_outcomes":100,"sex":161,"minimum_age":162,"maximum_age":163,"healthy_volunteers":14,"eligibility_criteria":164,"std_ages":168,"locations":171,"central_contacts":189,"overall_officials":191,"references":193,"see_also_links":194},"NCT05670288","IRB-300010011","Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury","RECRUITING","2027-02-28","2025-12","2025-12-17","2023-10-15","University of Alabama at Birmingham","OTHER",false,"The Investigators will recruit 35 participants with acute SCI (within 6 weeks of injury) Fasting blood collection and bowel function survey will be conducted 3 times: at baseline \\[within 6 weeks of injury\\], 6, and 12 months after SCI. Stool will be collected for gut microbiome analysis 3 times.","Stool and fasting blood collection will occur at the rehabilitation hospital (during in-patient stay) and at participants' homes. During the hospital stay, stool will be collected at the bedside by the research team and placed in a Para-pak® vial for sample preservation. Blood will also be collected by the research team.\n\nFor sample collection at home, a research nurse will travel to participants home to perform blood draws and bing back to the research lab for processing\u002Fanalysis\u002Fstorage.\n\nThe nurse may also collect the stool sample at the same time as the blood draw if available. If not, participants and their caregivers will be provided with a pre-paid\u002Flabeled FedEx package containing a stool collection kit (Para-pak® vial). Prior to bowel movement, participants and caregivers will be asked to clean the anal area using the sanitizing wipes; approximately 5-10 mL of stool will be transferred to the Para-pak® vial using the attached spatula in the Para-pak® vial. For participants who conduct their bowel management program in their beds, an additional sterile absorbent pad will be provided to use as a barrier between the bed and the participant to limit contamination. FedEx package containing the stool sample will be shipped to the investigators' lab\n\nFor each participant, the Investigators will record 1) diet (via 24-hour dietary recalls), 2) physical activity habits (via the rehabilitation therapies survey included in the SCI common data elements \\[CDEs\\], 3)Leisure Time Physical Activity Questionnaire; 4)depression and anxiety (via Patient Health Questionnaire-9 \\[PHQ9\\] and the General Anxiety Disorder-7 scale (GAD7),respectively); 5)prescribed medications, including antibiotics (via RedCap platform); 6)use of supplements and bowel routine components, including probiotics and laxatives (via self-report); and 7)any other comorbidities beyond GI dysfunction",[18,19],"Spinal Cord Injuries","Gut Microbiome",[21,22,23,24,25],"SCI","Inflammation","Bowel Function","Blood Sugar","Lipid Profiles","OBSERVATIONAL",null,[],{"count":30,"type":31},35,"ESTIMATED",[],[34,38,41,44,47,49,50,51,52,54,55,56,57,60,62,63,64,67,68,69,70,73,74,75,76,79,80,81,82,85,86,87,88,91,94,95,96,97,98,99],{"measure":35,"description":36,"timeFrame":37},"Neurological impairment - Injury level by ISNCSCI","Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam","Baseline",{"measure":39,"description":40,"timeFrame":37},"Neurological impairment - Injury level by AIS","Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.",{"measure":42,"description":43,"timeFrame":37},"Neurological impairment - completeness of injury by ISNCSCI","Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam",{"measure":45,"description":46,"timeFrame":37},"Neurological impairment - completeness of injury by AIS","Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.",{"measure":35,"description":36,"timeFrame":48},"Month 6",{"measure":39,"description":40,"timeFrame":48},{"measure":42,"description":43,"timeFrame":48},{"measure":45,"description":46,"timeFrame":48},{"measure":35,"description":36,"timeFrame":53},"Month 12",{"measure":39,"description":40,"timeFrame":53},{"measure":42,"description":43,"timeFrame":53},{"measure":45,"description":46,"timeFrame":53},{"measure":58,"description":59,"timeFrame":37},"Microbiome composition - Bacterial 16S rRNA sequincing","Bacterial 16S rRNA sequencing will be performed",{"measure":58,"description":59,"timeFrame":61},"Month 1",{"measure":58,"description":59,"timeFrame":48},{"measure":58,"description":59,"timeFrame":53},{"measure":65,"description":66,"timeFrame":37},"Microbiome composition - Metagenomics","A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.",{"measure":65,"description":66,"timeFrame":61},{"measure":65,"description":66,"timeFrame":48},{"measure":65,"description":66,"timeFrame":53},{"measure":71,"description":72,"timeFrame":37},"Gut derived metabolites","Blood will be collected and serum extract metabolites will be isolated",{"measure":71,"description":72,"timeFrame":61},{"measure":71,"description":72,"timeFrame":48},{"measure":71,"description":72,"timeFrame":53},{"measure":77,"description":78,"timeFrame":37},"Analysis of metabolic markers to determine metabolic function","Blood will be collected and serum assays for metabolic markers performed",{"measure":77,"description":78,"timeFrame":61},{"measure":77,"description":78,"timeFrame":48},{"measure":77,"description":78,"timeFrame":53},{"measure":83,"description":84,"timeFrame":37},"Analysis of inflammatory markers to determine Inflammatory state","Blood will be collected and serum assays for inflammatory markers performed",{"measure":83,"description":84,"timeFrame":61},{"measure":83,"description":84,"timeFrame":48},{"measure":83,"description":84,"timeFrame":53},{"measure":89,"description":90,"timeFrame":37},"Bowel function - International Bowel Function Basic and Extended Data Set Assessment","International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.",{"measure":92,"description":93,"timeFrame":37},"Bowel function - Bristol Stool Scale","Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.",{"measure":89,"description":90,"timeFrame":61},{"measure":92,"description":93,"timeFrame":61},{"measure":89,"description":90,"timeFrame":48},{"measure":92,"description":93,"timeFrame":48},{"measure":89,"description":90,"timeFrame":53},{"measure":92,"description":93,"timeFrame":53},[101,104,105,106,107,110,113,114,115,116,117,118,119,122,125,126,127,128,129,130,131,134,137,138,139,140,141,142,143,146,147,148,149,152,153,154,155,158,159,160],{"measure":102,"description":103,"timeFrame":37},"Diet","Participant records 24-hour dietary recalls",{"measure":102,"description":103,"timeFrame":61},{"measure":102,"description":103,"timeFrame":48},{"measure":102,"description":103,"timeFrame":53},{"measure":108,"description":109,"timeFrame":37},"Physical activity - PARA-SCI","Complete PARA-SCI questionnaire to determine physical activity level",{"measure":111,"description":112,"timeFrame":37},"Physical activity - CDEs","Complete rehabilitation therapies survey (CDEs) to determine physical activity level",{"measure":108,"description":109,"timeFrame":61},{"measure":111,"description":112,"timeFrame":61},{"measure":108,"description":109,"timeFrame":48},{"measure":111,"description":112,"timeFrame":48},{"measure":108,"description":109,"timeFrame":53},{"measure":111,"description":112,"timeFrame":53},{"measure":120,"description":121,"timeFrame":37},"Medication List - Medical Record Review","Medical record review of prescribed medications being taken",{"measure":123,"description":124,"timeFrame":37},"Medication List - Self-report","Self-report of prescribed medications being taken",{"measure":120,"description":121,"timeFrame":61},{"measure":123,"description":124,"timeFrame":61},{"measure":120,"description":121,"timeFrame":48},{"measure":123,"description":124,"timeFrame":48},{"measure":120,"description":121,"timeFrame":53},{"measure":123,"description":124,"timeFrame":53},{"measure":132,"description":133,"timeFrame":37},"Supplement usage - Medical Record Review","Medical record review of supplements being taken",{"measure":135,"description":136,"timeFrame":37},"Supplement usage - self-report","Self-report of supplements being taken",{"measure":132,"description":133,"timeFrame":61},{"measure":135,"description":136,"timeFrame":61},{"measure":132,"description":133,"timeFrame":48},{"measure":135,"description":136,"timeFrame":48},{"measure":132,"description":133,"timeFrame":53},{"measure":135,"description":136,"timeFrame":53},{"measure":144,"description":145,"timeFrame":37},"Depression","Complete PHQ9 questionnaires to determine depression level",{"measure":144,"description":145,"timeFrame":61},{"measure":144,"description":145,"timeFrame":48},{"measure":144,"description":145,"timeFrame":53},{"measure":150,"description":151,"timeFrame":37},"Anxiety","Complete GAD7 questionnaire to determine anxiety level",{"measure":150,"description":151,"timeFrame":61},{"measure":150,"description":151,"timeFrame":48},{"measure":150,"description":151,"timeFrame":53},{"measure":156,"description":157,"timeFrame":37},"Comorbidities","Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction",{"measure":156,"description":157,"timeFrame":61},{"measure":156,"description":157,"timeFrame":48},{"measure":156,"description":157,"timeFrame":53},"ALL","18 Years","85 Years",{"inclusion":165,"exclusion":166,"raw_text":167},[],[],"Inclusion Criteria:\n\n1. 18-85 years of age\n2. diagnosis of traumatic SCI at the cervical to lumbar level (C3-L2)\n3. classification of A, B, C (motor complete, incomplete).\n\nExclusion Criteria:\n\n1. Women who are pregnant prior to consent\n2. neurological impairment other than SCI\n3. self-reported history of Crohn's disease or diverticulitis\n4. irritable bowel syndrome\n5. gastric blockage\u002Fobstruction or swallowing disorder\n6. prior GI surgery\n7. intrathecal pump\n8. concurrent usage of functional electrical stimulation for bowel management (e.g., constipation).\n9. able to ambulate",[169,170],"ADULT","OLDER_ADULT",[172],{"facility":173,"status":7,"city":174,"state":175,"zip":176,"country":177,"contacts":178,"geoPoint":186},"The University of Alabama at Birmingahm","Birmingham","Alabama","35294","United States",[179,184],{"name":180,"role":181,"phone":182,"email":183},"Jereme Wilroy, PhD","CONTACT","(205) 934-0355","jdwilroy@uab.edu",{"name":180,"role":185},"PRINCIPAL_INVESTIGATOR",{"lat":187,"lon":188},33.52066,-86.80249,[190],{"name":180,"role":181,"phone":182,"email":183},[192],{"name":180,"affiliation":12,"role":185},[],[],{"nct_id":4,"conditions":196,"biomarkers":198},[197],"Spinal Cord Injury",[],{"nct_id":4,"found":200,"summary":201,"prompt_version":211},true,{"design":202,"status":203,"heading":204,"summary":205,"follow_up":206,"word_count":207,"commitments":208,"compensation":209,"drugs_mentioned":210},"This is an observational study involving 35 participants. It is not testing a specific intervention or drug.","completed","Observational Study on Gut Microbiome After Spinal Cord Injury","This study is looking at how the gut microbiome (the community of bacteria in your intestines) changes during the first year after a spinal cord injury (SCI). Researchers want to understand if these changes are linked to metabolic (how your body uses energy) and bowel function. They will observe 35 people who have had a recent traumatic SCI (within 6 weeks of injury) affecting their neck or back (C3-L2 level). You could be eligible if you are between 18 and 85 years old and have a specific type of SCI. The study will involve collecting blood and stool samples, and asking about bowel function, at three different times over one year. The goal is to learn more about the connection between your gut health and recovery after SCI.","Participants will be followed for 12 months after their spinal cord injury.",128,"You would have blood and stool samples collected, and complete a bowel function survey, at baseline (within 6 weeks of injury), 6 months, and 12 months after your SCI.","Not stated in the trial record.",[],"v2"]