Efficacy of Fecal Microbiota Transplantation in ICU Patients With Gastrointestinal Dysfunction

Launched by WUHAN UNION HOSPITAL, CHINA · Sep 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of fecal microbiota transplantation (FMT) to help critically ill patients in the ICU who are experiencing gastrointestinal dysfunction. FMT is a treatment that involves transferring healthy bacteria from a donor's stool into a patient's intestines to improve gut health and function. The researchers want to see if this treatment can help patients recover better, stay in the ICU for a shorter time, and reduce the risk of death during their hospital stay.

To be eligible for this study, patients need to be between 18 and 70 years old, have been in the ICU for at least 24 hours, and expect to stay for at least 7 days. They should also be experiencing some issues with their gastrointestinal system. Participants will receive the FMT treatment and will be monitored for their recovery and overall health. It’s important to note that some patients, such as those with severe infections or certain medical conditions, may not qualify for this trial. Overall, this study aims to explore a new way to support gut health in critically ill patients, which could lead to better outcomes.

Gender

ALL

Eligibility criteria

• 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;
• • 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.