Using fecal microbiota transplantation to improve gut function in ICU patients

Efficacy of Fecal Microbiota Transplantation in Critically Ill ICU Patients With Gastrointestinal Dysfunction: a Single-center, Non-blind, Randomized Controlled Study

This study tests whether giving a special treatment using healthy gut bacteria can help critically ill patients in the ICU recover their gut function and possibly shorten their hospital stay.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Wuhan Union Hospital, China (Academic / other)
• Drugs / interventions: rituximab, doxorubicin
• Locations: 2 sites (Wuhan, Hubei and 1 other locations)
• Trial ID: NCT06603883 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of fecal microbiota transplantation (FMT) on gastrointestinal dysfunction in critically ill patients admitted to the ICU. It aims to assess how FMT can aid in the recovery of gut function, improve gastrointestinal barrier integrity, and potentially reduce ICU stay and mortality rates. Patients will receive FMT via a nasal jejunal tube, and the study will monitor various clinical outcomes including length of ICU stay and mortality rates over a 28-day period. The research focuses on patients who have been in the ICU for at least 24 hours and exhibit signs of gastrointestinal dysfunction.

Who should consider this trial

Good fit: Ideal candidates are ICU patients aged 8 to 70 years with gastrointestinal dysfunction who are expected to stay in the ICU for at least 7 days.

Not a fit: Patients with severe systemic infections, hemodynamic instability, or those at high risk of death within 5 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery times and outcomes for critically ill patients with gastrointestinal dysfunction.

How similar studies have performed: While the use of FMT in critically ill patients is a relatively novel approach, preliminary studies have shown promise in improving gut health and clinical outcomes.

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.

Where this trial is running

Wuhan, Hubei and 1 other locations

• Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (Recruiting)

Study contacts

• Principal investigator: Jiancheng Zhang, Dr. — Wuhan Union Hospial
• Study coordinator: Jiancheng Zhang, Dr.

Conditions Gastrointestinal Dysfunction; FMT; Gastrointestinal dysfunction; ICU