[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600048":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":67,"collaborators":69,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":26,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Tang-Du Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","Patients will receive semi-elemental enteral nutrition.",[13],"Dietary Supplement: Semi-elemental formula",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","ACTIVE_COMPARATOR","Patients will receive standard enteral nutrition.",[19],"Dietary Supplement: Standard formula",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Semi-elemental formula","Treatment: Semi-elemental enteral nutrition Objective: To assess the efficacy of semi-elemental enteral nutrition in enhancing gastrointestinal tolerance in patients with severe traumatic brain injury.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard formula","Treatment: Standard enteral nutrition Objective: To serve as the control for evaluating the efficacy and safety of semi-elemental enteral nutrition versus standard nutritional therapy",[15],[32],{"name":33,"affiliation":5,"role":34},"Yan Qu, MD, PhD","STUDY_CHAIR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Haixiao Liu, MD, PhD","CONTACT","+86-029-84717556","hai_xiao_liu@163.com",{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},"Hao Guo, MD, PhD","guohao0622@163.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Tangdu Hospital","RECRUITING","Xi'an","Shaanxi","710038","China","CN",{"type":54,"coordinates":55},"Point",[56,57],108.92861,34.25833,{"lat":57,"lon":56},[60,64],{"name":61,"role":38,"phone":62,"phoneExt":26,"email":63},"Haixiao Liu, PhD, MD","+86-02984778359","lhxiao@fmmu.edu.cn",{"name":65,"role":66,"phone":26,"phoneExt":26,"email":26},"Yan Qu, PhD, MD","PRINCIPAL_INVESTIGATOR",{"type":68,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[70,72,74,76,78,80,82,84,86,88,90,92],{"name":71,"class":6},"Ankang Central Hospital",{"name":73,"class":6},"Qilu Hospital of Shandong University (Qingdao)",{"name":75,"class":6},"960th Hospital of Joint Logistics Support Force of People's Liberation Army of China",{"name":77,"class":6},"904th Hospital of the Joint Logistics Support Force of the PLA",{"name":79,"class":6},"West China Hospital",{"name":81,"class":6},"Qianfoshan Hospital",{"name":83,"class":6},"The First Affiliated Hospital of Xinxiang Medical College",{"name":85,"class":6},"Hanzhong Central Hospital",{"name":87,"class":6},"The General Hospital of Western Theater Command",{"name":89,"class":6},"The General Hospital of Northern Theater Command",{"name":91,"class":6},"Tangshan Gongren Hospital",{"name":93,"class":6},"987th Hospital of the Chinese People's Liberation Army Joint Logistic Support Force","100600048","effect-of-semi-elemental-enteral-nutrition-on-gastrointestinal-tolerance-in-patients-with-traumatic-brain-injury-100600048",false,"NCT07092423","Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury.","The Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury: a Randomized Exploratory Study","SEMINAR","Inclusion Criteria:\n\n* Aged 18-75 years;\n* Clinically diagnosed with closed traumatic brain injury;\n* Glasgow Coma Scale (GCS) score ≤ 8;\n* Ability to initiate enteral nutrition within 48 hours post-injury;\n* Expected need for enteral nutrition support ≥3 days based on clinical assessment (Nutritional Risk Screening 2002 \\[NRS2002\\] score ≥3).\n\nExclusion Criteria:\n\n* GCS=3 with bilateral fixed and dilated pupils;\n* Hemodynamic instability or respiratory failure: mean arterial pressure \\\u003C70mmHg, PaO2\u002FFiO2\\\u003C150, PaCO2\\\u003C30 mmHg or \\>45 mmHg, or lactate \\>5 mmol\u002Fl;\n* Contraindications to both nasogastric and nasojejunal tube placement, or inability to complete tube placement within 48 hours of onset;\n* Contraindications to enteral nutrition therapy or semi-recumbent positioning;\n* Pre-existing intellectual disability or physical disability affecting outcome assessment;\n* Gastrointestinal abnormalities likely to affect gastrointestinal function, such as short bowel syndrome (defined as total small bowel length ≤122 cm), ulcerative colitis, Crohn's disease, or any form of ostomy;\n* Body mass index (BMI) \\\u003C18kg\u002Fm2;\n* Concomitant abdominal injury or extracranial injury with AIS score \\>3 in any region;\n* Presence of malignancy, severe cardiac insufficiency (ejection fraction \\\u003C50%), severe hepatic failure (Child-Pugh score ≥7), or severe renal failure (glomerular filtration rate ≤30 mL\u002Fmin or serum creatinine ≥4mg\u002FdL) at NICU admission;\n* Concurrent severe disease with expected survival ≤14 days;\n* Pregnancy, within 30 days postpartum, or breastfeeding;\n* Refusal of treatment or receipt of palliative care;\n* Patient or family declines informed consent;\n* Current participation in another interventional clinical trial.","ALL","18 Years","75 Years",{"count":106,"type":107},100,"ESTIMATED","INTERVENTIONAL",[110],"NA","Study Objective This clinical trial primarily aims to investigate whether semi-elemental enteral nutrition (SEN) improves gastrointestinal tolerance in patients with severe traumatic brain injury (TBI) and to evaluate its impact on clinical outcomes. The safety profile of SEN will also be assessed.\n\nKey Research Questions Does SEN reduce the incidence of acute gastrointestinal injury (AGI) in severe TBI patients?\n\nStudy Design\n\nParticipants will be randomized 1:1 into either:\n\nIntervention group: Receives SEN initiated within 48 hours post-injury and continued for ≥7 days.\n\nControl group: Receives standard enteral nutrition over the same period.",[113,114,115],"Traumatic Brain Injury","Neurocritical Care","Enteral Feeding Intolerance",[113,117,118,119,114,120],"Enteral Nutrition","Gastrointestinal Intolerance","Semi-elemental Formula","Prognosis","2026-04-26",{"date":123,"type":124},"2026-04-30","ACTUAL",{"date":126,"type":124},"2025-05-18",{"date":128,"type":107},"2027-05-31",{"name":5,"class":6},1]