Efficacy of Fecal Microbiota Transplantation in ICU Patients With Gastrointestinal Dysfunction

Phase 2

Recruiting

• Conditions: Gastrointestinal Dysfunction
• Interventions: Biological: Fecal microbiota transplantation (FMT) by nasal jejunal tube

• Registration Number: NCT06603883
• Lead Sponsor: Wuhan Union Hospital, China

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.

Study Timeline

• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-17
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Study Start: 2024-10-19
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FMT intervention Group	Fecal microbiota transplantation (FMT) by nasal jejunal tube	In addition to ICU standard treatment, 50ml commercial intestinal bacterial suspension was administered via a naso-jejunal tube to the jejunum from 11:00 to 13:00 every day for 3 consecutive days.

Primary Outcome Measures

Name	Time	Method
Percentage of the effective improvement of primary gastrointestinal dysfunction	24, 48, 72, 96, 120 hours and 10 days after inclusion.	Change of food intolerance syndrome. Change of intraperitoneal hypertension. Change of massive gastric retention. Change of diarrhea. Change of lower digestive tract paralysis. Change of intestinal dilation.

Secondary Outcome Measures

Name	Time	Method
Changes of intestinal microbiota and its metabolites	0, 24, 48, 72, 96, 120 hours and 30 days after inclusion.	Rectal swab was taken and analysed by 16S rRNA gene sequencing and metabolomics.
Intestinal barrier function	0, 24, 48, 72, 96, 120 hours after inclusion.	2ml of peripheral venous blood was collected for the measurement of serum lipopolysaccharide (LPS), diamine oxidase (DAO), and D-lactic acid.
Acute gastrointestinal injury (AGI) score	0, 24, 48, 72, 96 and 120 hours after inclusion.	Acute gastrointestinal injury (AGI) score is quoted from the "Expert consensus on enteral nutrition for gastrointestinal dysfunction in critically ill patients (2021 edition)". AGI can be divided into Ⅰ, Ⅱ, Ⅲ and Ⅳ grades, and the higher the grade, the more serious the gastrointestinal dysfunction.
Acute Physiology and Chronic Health Evaluation (APACHE) Ⅱ score	0, 24, 48, 72, 96, 120 hours after inclusion.	Acute Physiology and Chronic Health Evaluation (APACHE) Ⅱ score is a scoring system used to assess the severity of critically ill patients. APACHE II score ranges from 0 to 71. The higher the score, the greater the severity and the poorer the prognosis.
Usage of vasoactive drugs	0, 24, 48, 72, 96, 120 hours after inclusion.	Total doses of vasoactive drugs used within 24, 48, 72, 96, and 120 hours after inclusion.
C-reactive protein (CRP) and procalcitonin (PCT)	0, 24, 48, 72, 96, 120 hours after inclusion.	2ml of peripheral venous blood was collected for the measurement of CRP and PCT.
Peripheral blood cytokines and lymphocyte subsets	0 hour and 96 hours after inclusion.	2ml of peripheral venous blood was collected for the measurement of the levels of cytokines and the absolute number of lymphocyte subsets.
ICU length of stay	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	The number of days spent in the ICU.
ICU mortality	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	Mortality rate of patients in each group during their stay in the ICU.
In-hospital mortality	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	Mortality rate of patients in each group during hospitalization.
28-day mortality	28 days after inclusion.	Mortality rate of patients in each group within 28 days after inclusion.

Trial Locations

Locations (1)

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, China