Efficacy of Fecal Microbiota Transplantation in ICU Patients With Gastrointestinal Dysfunction-in… (NCT06603883) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy of Fecal Microbiota Transplantation in ICU Patients With Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance
China19 participantsStarted 2024-10-19
Plain-language 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 nutrition intolerance in critically ill ICU patients. The purpose of this study was to investigate the effects of FMT on the recovery of gastrointestinal dysfunction-induced enteral nutrition intolerance in critically ill patients admitted to ICU, and observe the effects on gastrointestinal barrier function, as well as the effects on length of stay in ICU, ICU mortality, in-hospital mortality, and 28-day mortality.
Who can participate
Age range18 Years – 70 Years
SexALL
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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;
✕
What they're measuring
1
Percentage of the effective improvement of enteral nutrition intolerance
Timeframe: 24, 48, 72 and 96 hours after first FMT.
Trial details
NCT IDNCT06603883
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
. 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;