Efficacy of Fecal Microbiota Transplantation in ICU Patients With Gastrointestinal Dysfunction-in… (NCT06603883) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy of Fecal Microbiota Transplantation in ICU Patients With Gastrointestinal Dysfunction-induced Enteral Nutrition Intolerance
China19 participantsStarted 2024-10-19
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of the effective improvement of enteral nutrition intolerance
Timeframe: 24, 48, 72 and 96 hours after first FMT.
Trial details
NCT IDNCT06603883
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
. 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;