Status:
RECRUITING
Efficacy of Fecal Microbiota Transplantation in ICU Patients With Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Considering that intestinal microbiota plays a crucial role in intestinal function, fecal microbiota transplantation (FMT) may provide a new therapeutic strategy for the treatment of intestinal nutrit...
Detailed Description
Patients in the intensive care unit (ICU) are often at risk for gastrointestinal dysfunction and malnutrition. Gastrointestinal dysfunction is associated with poorer clinical outcomes, including longe...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 8 ≤ age ≤ 70 years old, any nationality, any gender;
- Female patients have no potential fertility (i.e., no physical ability to conceive, including women who have been menopausal for 2 years) or no pregnancy plan;
- Patients who have been in the ICU for at least 24 hours;
- Patients with an expected ICU stay of at least 7 days;
- Non-acute patients with at least one manifestation of gastrointestinal dysfunction leading to enteral nutrition intolerance;
- Patients can cooperate or passively complete the relevant examination and complete the follow-up;
- Informed consent is documented by means of a written, signed and dated informed consent form.
- Exclusion Criteria:
- Severe systemic infection, in early recovery period, hemodynamic instability or tissue hypoperfusion, severe imbalances in water and electrolyte status;
- Patients who are considered by clinicians to be at high risk of death within 5 days, or who are subject to restricted treatment decisions;
- Severe damage of intestinal barrier such as active massive bleeding and perforation of digestive tract;
- Patients who cannot tolerate 50% of caloric calorie requirements with enteral nutrition due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high-flow intestinal fistula and other reasons;
- Nasal jejunal tube cannot be placed;
- Planned or recent abdominal surgery (within 14 days);
- Currently diagnosed with fulminant colitis or toxic megacolon;
- Neutropenia (neutrophil count \< 1500 /µL);
- Patients with congenital or acquired immune deficiency;
- Malignant hematologic diseases, such as lymphoma;
- Autoimmune diseases;
- Patients who have recently received high-risk immunosuppressive or cytotoxic drugs, such as rituximab, doxorubicin, or medium-high dose of steroid hormones (20mg/day or higher) for more than 4 weeks;
- Pregnant or lactating women;
- Participating in other clinical studies as a participant at the time of enrollment or within 3 months before inclusion;
- Informed consent can not be obtained.
Exclusion
Key Trial Info
Start Date :
October 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06603883
Start Date
October 19 2024
End Date
October 31 2026
Last Update
December 18 2025
Active Locations (2)
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1
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
2
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China