Clinical trial NCT06603883: Efficacy of Fecal Microbiota Transplantation in ICU Patients With Gastrointestinal Dysfunction
Official title: Efficacy of Fecal Microbiota Transplantation in Critically Ill ICU Patients With Gastrointestinal Dysfunction: a Single-center, Non-blind, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Gastrointestinal Dysfunction
Keywords: FMT
Gastrointestinal dysfunction
ICU
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 gastrointestinal dysfunction in critically ill ICU patients. The purpose of this study was to investigate the effects of FMT on the recovery of gastrointestinal dysfunction 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.

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 longer mechanical ventilation, longer ICU stay, and increased 90-day mortality. Due to the influence of primary severe diseases and the use of proton pump inhibitors (PPI) and antibiotics, ICU patients with severe illness may have severe disturbance of intestinal flora, impairment of intestinal barrier function, high incidence of gastrointestinal dysfunction, and severe intestinal systemic inflammation and organ function injury. 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 gastrointestinal dysfunction in critically ill ICU patients. The project plans through nasal jejunal tube way to give FMT, to investigate its effect on gastrointestinal function recovery in severe patients with gastrointestinal dysfunction admitted to ICU, and to observe its effect on gastrointestinal barrier function.

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.

Primary outcomes:
measure: Percentage of the effective improvement of primary gastrointestinal dysfunction
timeFrame: 24, 48, 72, 96, 120 hours and 10 days after inclusion.
Secondary outcomes:
measure: Changes of intestinal microbiota and its metabolites
timeFrame: 0, 24, 48, 72, 96, 120 hours and 30 days after inclusion.
measure: Intestinal barrier function
timeFrame: 0, 24, 48, 72, 96, 120 hours after inclusion.
measure: Acute gastrointestinal injury (AGI) score
timeFrame: 0, 24, 48, 72, 96 and 120 hours after inclusion.
measure: Acute Physiology and Chronic Health Evaluation (APACHE) Ⅱ score
timeFrame: 0, 24, 48, 72, 96, 120 hours after inclusion.
measure: Usage of vasoactive drugs
timeFrame: 0, 24, 48, 72, 96, 120 hours after inclusion.
measure: C-reactive protein (CRP) and procalcitonin (PCT)
timeFrame: 0, 24, 48, 72, 96, 120 hours after inclusion.
measure: Peripheral blood cytokines and lymphocyte subsets
timeFrame: 0 hour and 96 hours after inclusion.
measure: ICU length of stay
timeFrame: From date of randomization until the date of discharge from the ICU or date of death from any cause during ICU stay, whichever came first, assessed up to 6 weeks
measure: ICU mortality
timeFrame: From date of randomization until the date of discharge from the ICU or date of death from any cause during ICU stay, whichever came first, assessed up to 6 weeks
measure: In-hospital mortality
timeFrame: From date of randomization until the date of discharge from the hospital or date of death from any cause during hospitalization, whichever came first, assessed up to 6 weeks
measure: 28-day mortality
timeFrame: 28 days after inclusion.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study officials:
affiliation: Wuhan Union Hospial
name: Jiancheng Zhang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: