Yükleniyor... / Loading...
This study evaluates the effect of fecal microbiota transplantation (transfer of gut bacteria from donor stool) in intensive care patients who cannot tolerate tube feeding because of gastrointestinal dysfunction. Patients aged 8-70 who had been in the ICU for at least 24 hours were able to take part. It was conducted in Phase 2/Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion criteria: 1. 8 ≤ age ≤ 70 years old, any nationality, any gender; 2. 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; 3. Patients who have been in the ICU for at least 24 hours; 4. Patients with an expected ICU stay of at least 7 days; 5. Non-acute patients with at least one manifestation of gastrointestinal dysfunction leading to enteral nutrition intolerance; 6. Patients can cooperate or passively complete the relevant examination and complete the follow-up; 7. Informed consent is documented by means of a written, signed and dated informed consent form. Exclusion Criteria: 1. Severe systemic infection, in early recovery period, hemodynamic instability or tissue hypoperfusion, severe imbalances in water and electrolyte status; 2. Patients who are considered by clinicians to be at high risk of death within 5 days, or who are subject to restricted treatment decisions; 3. Severe damage of intestinal barrier such as active massive bleeding and perforation of digestive tract; 4. 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; 5. Nasal jejunal tube cannot be placed; 6. Planned or recent abdominal surgery (within 14 days); 7. Currently diagnosed with fulminant colitis or toxic megacolon; 8. Neutropenia (neutrophil count \< 1500 /µL); 9. Patients with congenital or acquired immune deficiency; 10. Malignant hematologic diseases, such as lymphoma; 11. Autoimmune diseases; 12. 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; 13. Pregnant or lactating women; 14. Participating in other clinical studies as a participant at the time of enrollment or within 3 months before inclusion; 15. Informed consent can not be obtained.