Poop pills for ICU patients? new trial tests fecal transplants for feeding troubles
NCT ID NCT07640633
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This study tests whether fecal microbiota transplantation (FMT) can help critically ill ICU patients who have trouble with tube feeding due to gut problems. Researchers will give 60 patients either standard care plus FMT or standard care alone. They will measure how well the gut recovers and whether feeding improves.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fecal microbiota transplantation (FMT)
- What this could lead to
- If it works, this could offer a new way to help critically ill patients tolerate feeding and recover gut function faster.
- What could go wrong
- This is a small, early-stage trial with only 60 patients at one hospital. The treatment may not work or could cause side effects like infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 to 70 years inclusive, regardless of ethnicity or gender; 2. Female participants are either non-fertile (i.e., physiologically incapable of pregnancy, including women with ≥2 years of menopause) or have no pregnancy plans; 3. Have been admitted to the ICU for ≥24 hours; 4. Expected ICU stay ≥7 days after study enrollment; 5. Screened positive for ≥1 manifestation of gastrointestinal dysfunction (intra-abdominal hypertension \[IAH\], massive gastric retention, diarrhea, lower gastrointestinal paralysis, bowel dilatation); enteral nutrition is then implemented under the guidance of the enteral feeding intolerance (FI) score, and participants with persistent FI after a 3-day trial are formally enrolled; 6. Participants can actively cooperate or passively complete relevant examinations and follow-up procedures; 7. Have signed a written informed consent form. Exclusion Criteria: 1. Severe systemic infection in the early resuscitation phase, with hemodynamic instability, insufficient tissue perfusion, or severe fluid-electrolyte and acid-base imbalances; 2. Patients assessed by clinicians as having a high risk of death within 5 days, or those with restricted treatment decisions; 3. Active gastrointestinal bleeding, perforation, or other conditions with severe intestinal barrier impairment; 4. Patients unable to tolerate enteral nutrition meeting 50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stenosis, massive gastrointestinal bleeding, or high-output enterocutaneous fistula; 5. Planned or recent abdominal surgery (within 14 days prior to enrollment); 6. Current diagnosis of fulminant colitis or toxic megacolon; 7. Neutropenia (neutrophil count \< 1500 cells/µL); 8. Patients with congenital or acquired immunodeficiency disorders; 9. Recent receipt of high-risk immunosuppressive or cytotoxic agents, e.g., rituximab, doxorubicin, or medium-to-high-dose corticosteroids (≥ 20 mg/day prednisone equivalent) for a duration of \> 4 weeks; 10. Pregnant or lactating women; 11. Participation in another clinical trial as a subject at the time of enrollment or within 3 months prior to enrollment; 12. Doubtful validity of informed consent: subjects with mental illness, intellectual disability, poor motivation, or other factors that restrict the validity of informed consent for participation in this study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 460022, China
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