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Research Plan for Key Technologies in Targeted Repair of Gut Microecology and Synergistic Reconstruction of Multi-Organ Functions in Severely Disabled Patients

Research Plan for Key Technologies in Targeted Repair of Gut Microecology and Synergistic Reconstruction of Multi-Organ Functions in Severely Disabled Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112459
Enrollment
Unknown
Registered
2025-11-14
Start date
2025-11-18
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent consciousness impairment (GCS <=12 points) and tracheotomy status due to cerebral hemorrhage or traumatic brain injury

Interventions

Mildly Disabled Patient Group:None
Severe Disabled Patient Group:None

Sponsors

Shandong Provincial Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Critically ill patients (1) Underlying conditions: persistent consciousness disorder caused by cerebral hemorrhage/traumatic brain injury (GCS 50% of caloric needs, or enteral nutrition formula same as that for severe cases; (4) Medical exposure: same ward environment, same frequency of disinfectant use; (5) Antibiotic use: only prophylactic use (72 hours ago; 3. Healthy Volunteers (1) Healthy individuals without active infections and without neurological dysfunction.

Exclusion criteria

Exclusion criteria: 1. Critically Ill Patients (1) Organic intestinal diseases, active gastrointestinal bleeding, colorectal cancer; (2) Metabolic failure, liver failure (Child-Pugh class C) or renal failure (eGFR 20mg/day), HIV infection, hematologic malignancies; (4) Recent microbiota interventions, use of probiotics/prebiotics in the past month or previous FMT treatment; (5) Antibiotic exposure, use of carbapenems or polymyxins within 72 hours prior to enrollment; (6) Risk of intestinal ischemia, mesenteric artery stenosis >70%, shock requiring vasopressors (norepinephrine >0.3 µg/kg/min); (7) Expected survival, anticipated survival 60); 2. Mild Patients (1) Infection or inflammation, WBC > 10×10^9/L or CRP > 10 mg/L; (2) Gastrointestinal diseases, presence of intestinal obstruction, inflammatory bowel disease, or history of gastrointestinal surgery; (3) Neurological impairment, presence of consciousness disorder (GCS 0.05 ng/mL; (2) Presence of digestive system diseases, constipation (3 times/day), IBS symptoms; (3) Use of antibiotics, probiotics, or immunomodulators in the past 3 months.

Design outcomes

Primary

MeasureTime frame
Resistant bacteria load;Basic physiology;basal metabolism;Gastrointestinal Function;

Secondary

MeasureTime frame
Metabolic Nutrition;Neural functions;immunologic function;Inflammatory levels;

Countries

China

Contacts

Public ContactShanshan Wang

Shandong Provincial Third Hospital

35111972@qq.com+86 531 81656920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026