Efficacy of Fecal Microbiota Transplantation in ICU Patients With Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance

Efficacy of Fecal Microbiota Transplantation in Critically Ill ICU Patients With Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance: a Single-center, Non-blind, Exploratory Study

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance
• Intervention / Treatment: Biological: Fecal microbiota transplantation (FMT) by nasal jejunal tube

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-induced enteral nutrition intolerance, 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-induced enteral nutrition intolerance in critically ill ICU patients. The project plans through nasal jejunal tube way to give FMT, to investigate its effect on the recovery of gastrointestinal dysfunction-induced enteral nutrition intolerance in severe patients admitted to ICU, and to observe its effect on gastrointestinal barrier function.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Wuhan, China
    • Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 leading to enteral nutrition intolerance;
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMT intervention Group; 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.	Biological: Fecal microbiota transplantation (FMT) by nasal jejunal tube; FMT was administered via a naso-jejunal tube to inject 50ml commercial intestinal bacterial suspension into the jejunum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of the effective improvement of enteral nutrition intolerance	Change of intestinal nutrition intolerance.	24, 48, 72 and 96 hours after first FMT.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	Mortality rate of patients in each group within 28 days after inclusion.	28 days after inclusion.
Changes of intestinal microbiota and its metabolites	Rectal swab was taken and analysed by 16S rRNA gene sequencing and metabolomics.	-48, 72 and 96 hours after first FMT.
Intestinal barrier function	2ml of peripheral venous blood was collected for the measurement of serum lipopolysaccharide (LPS), diamine oxidase (DAO), and D-lactic acid.	-24, 0, 24, 48, 72 and 96 hours after first FMT.
Acute Physiology and Chronic Health Evaluation (APACHE) Ⅱ score	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.	-48, -24, 0, 24, 48, 72 and 96 hours after first FMT.
Peripheral blood cytokines and lymphocyte subsets	2ml of peripheral venous blood was collected for the measurement of the levels of cytokines and the absolute number of lymphocyte subsets.	-24 and 72 hours after inclusion.
90-day mortality	Mortality rate of patients in each group within 90 days after inclusion.	90 days after inclusion.
C-reactive protein (CRP)	2ml of peripheral venous blood was collected for the measurement of CRP.	-48, -24, 0, 24, 48, 72 and 96 hours after first FMT.

Collaborators and Investigators

• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Investigators: Principal Investigator: Jiancheng Zhang, Dr., Wuhan Union Hospial

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2024
• Primary Completion (Actual): March 13, 2026
• Study Completion (Actual): March 13, 2026

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: ICU; FMT; Gastrointestinal dysfunction
• Additional Relevant MeSH Terms: Therapeutics; Biological Therapy; Fecal Microbiota Transplantation
• Other Study ID Numbers: ZJC202408

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No