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

NCT06603883 | Completed Phase 2

• 1 other identifier: ZJC202408
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance

Keywords

FMT; Gastrointestinal dysfunction; ICU

Outcome Measures

Primary Outcomes (1)

• Percentage of the effective improvement of enteral nutrition intolerance

  Change of intestinal nutrition intolerance.

  24, 48, 72 and 96 hours after first FMT.

Secondary Outcomes (7)

• Changes of intestinal microbiota and its metabolites

  -48, 72 and 96 hours after first FMT.

• Intestinal barrier function

  -24, 0, 24, 48, 72 and 96 hours after first FMT.

• Acute Physiology and Chronic Health Evaluation (APACHE) Ⅱ score

  -48, -24, 0, 24, 48, 72 and 96 hours after first FMT.

• C-reactive protein (CRP)

  -48, -24, 0, 24, 48, 72 and 96 hours after first FMT.

• Peripheral blood cytokines and lymphocyte subsets

  -24 and 72 hours after inclusion.

Study Arms (1)

FMT intervention Group

EXPERIMENTAL

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

Interventions

Fecal microbiota transplantation (FMT) by nasal jejunal tube BIOLOGICAL

FMT was administered via a naso-jejunal tube to inject 50ml commercial intestinal bacterial suspension into the jejunum.

FMT intervention Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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.

You may not qualify if:

• Severe systemic infection, in early recovery period, hemodynamic instability or tissue hypoperfusion, severe imbalances in water and electrolyte status;
• 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;
• Neutropenia (neutrophil count \< 1500 /µL);
• Patients with congenital or acquired immune deficiency;
• Malignant hematologic diseases, such as lymphoma;
• Autoimmune diseases;
• 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;
• Pregnant or lactating women;
• Informed consent can not be obtained.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (2)

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Jiancheng Zhang, Dr.

  Wuhan Union Hospial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Jiancheng Zhang

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: October 19, 2024
• Primary Completion: March 13, 2026
• Study Completion: March 13, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)