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

June 1, 2026 updated by: Jiancheng Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of the effective improvement of enteral nutrition intolerance
Time Frame: 24, 48, 72 and 96 hours after first FMT.
Change of intestinal nutrition intolerance.
24, 48, 72 and 96 hours after first FMT.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
28-day mortality
Time Frame: 28 days after inclusion.
Mortality rate of patients in each group within 28 days after inclusion.
28 days after inclusion.
Changes of intestinal microbiota and its metabolites
Time Frame: -48, 72 and 96 hours after first FMT.
Rectal swab was taken and analysed by 16S rRNA gene sequencing and metabolomics.
-48, 72 and 96 hours after first FMT.
Intestinal barrier function
Time Frame: -24, 0, 24, 48, 72 and 96 hours after first FMT.
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
Time Frame: -48, -24, 0, 24, 48, 72 and 96 hours after first FMT.
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
Time Frame: -24 and 72 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.
-24 and 72 hours after inclusion.
90-day mortality
Time Frame: 90 days after inclusion.
Mortality rate of patients in each group within 90 days after inclusion.
90 days after inclusion.
C-reactive protein (CRP)
Time Frame: -48, -24, 0, 24, 48, 72 and 96 hours after first FMT.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jiancheng Zhang, Dr., Wuhan Union Hospial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 13, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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