Gastrointestinal Dysfunction-induced Enteral Nutrition IntolerancePhase 2/3NCT06603883
Efficacy of Fecal Microbiota Transplantation in ICU Patients With Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance
A Phase 2/3 study testing Fecal microbiota transplantation (FMT) by nasal jejunal tube in people with Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance
- What is being tested?
- Fecal microbiota transplantation (FMT) by nasal jejunal tube
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesChina
- Study dates
- 19 Oct 2024to 13 Mar 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 8 ≤ 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.
Who cannot join
- 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);
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- 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;
- Participating in other clinical studies as a participant at the time of enrollment or within 3 months before inclusion;
- Informed consent can not be obtained.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
About this study
Official title: 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.
Read the 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.
- Being tested
- Fecal microbiota transplantation (FMT) by nasal jejunal tube
- Keywords
- FMT, Gastrointestinal dysfunction, ICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation (FMT) by nasal jejunal tubeBiological
FMT was administered via a naso-jejunal tube to inject 50ml commercial intestinal bacterial suspension into the jejunum.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Fecal microbiota transplantation (FMT) by nasal jejunal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of the effective improvement of enteral nutrition intolerance
Change of intestinal nutrition intolerance.
Measured: 24, 48, 72 and 96 hours after first FMT.
Secondary outcomes (7)
Changes of intestinal microbiota and its metabolites
Rectal swab was taken and analysed by 16S rRNA gene sequencing and metabolomics.
Measured: -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.
Measured: -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.
Measured: -48, -24, 0, 24, 48, 72 and 96 hours after first FMT.
C-reactive protein (CRP)
2ml of peripheral venous blood was collected for the measurement of CRP.
Measured: -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.
Measured: -24 and 72 hours after inclusion.
28-day mortality
Mortality rate of patients in each group within 28 days after inclusion.
Measured: 28 days after inclusion.
90-day mortality
Mortality rate of patients in each group within 90 days after inclusion.
Measured: 90 days after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Oct 2024
- Primary completion13 Mar 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Dysfunction-induced Enteral Nutrition IntoleranceStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiancheng Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Jiancheng Zhang, Dr., Principal investigator, Wuhan Union Hospial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603883
- Sponsor's protocol ID
- ZJC202408
- Status last verified
- Jun 2026
- First submitted
- 11 Sep 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fecal Microbiota Transplantation in Critically Ill ICU Patients With Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance: a Single-center, Non-blind, Exploratory Study
- ClinicalTrials.gov ID
- NCT06603883
- Acronym / sponsor ID
- ZJC202408
- Keywords
- FMT, Gastrointestinal dysfunction, ICU
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 19 Oct 2024 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMT intervention Group | Experimental | Biological: Fecal microbiota transplantation (FMT) by nasal jejunal tubeIn 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 8 ≤ 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantation (FMT) by nasal jejunal tubeFMT was administered via a naso-jejunal tube to inject 50ml commercial intestinal bacterial suspension into the jejunum. | Biological | FMT intervention Group |
Primary outcome
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.
7 secondary outcomes
Changes of intestinal microbiota and its metabolites
Time frame: -48, 72 and 96 hours after first FMT.
Intestinal barrier function
Time frame: -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.
C-reactive protein (CRP)
Time frame: -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.
28-day mortality
Time frame: 28 days after inclusion.
90-day mortality
Time frame: 90 days after inclusion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiancheng Zhang, Dr. principal investigator
Wuhan Union Hospial
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fecal microbiota transplantation (FMT) by nasal jejunal tube in people with Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of the effective improvement of enteral nutrition intolerance (time frame: 24, 48, 72 and 96 hours after first FMT.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.