Poop pills for ICU patients? small study shows promise for gut troubles
NCT ID NCT06603883
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether transplanting healthy gut bacteria (fecal microbiota transplantation) could help critically ill ICU patients who have trouble tolerating tube feeding due to gut problems. Nineteen patients received the treatment to see if it improved their ability to digest food, reduced inflammation, and shortened hospital stays. The goal was to find a new way to manage a common complication in intensive care.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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19 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Mar 2026
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
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Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China