Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 460022, China
NCT Number: NCT07640633
Critically ill patients admitted to the intensive care unit (ICU) frequently present with gastrointestinal dysfunction and are at elevated risk of malnutrition. Gastrointestinal dysfunction is correlated with adverse clinical outcomes, including prolonged mechanical ventilation duration, extended ICU length of stay, and increased 90-day mortality.
In critically ill ICU patients, severe gut microbiota dysbiosis and intestinal barrier impairment may occur due to the burden of primary critical illnesses, as well as the administration of proton pump inhibitors and antibiotics. This cascade contributes to a high prevalence of gastrointestinal dysfunction, alongside profound gut-derived systemic inflammatory responses and organ damage. Given the pivotal role of gut microbiota in maintaining intestinal homeostasis, fecal microbiota transplantation (FMT) holds promise as a novel therapeutic strategy for enteral feeding intolerance secondary to gastrointestinal dysfunction in critically ill ICU patients.
This study intends to deliver FMT via a nasojejunal tube to critically ill patients with gastrointestinal dysfunction admitted to the ICU. Its objectives are to evaluate the intervention's effects on gastrointestinal function recovery and the alleviation of enteral feeding intolerance, while also assessing its impacts on intestinal barrier function, gut microbiota composition and metabolic profiles, serum metabolite signatures, immune-inflammatory responses (including lymphocyte subsets, cytokines, C-reactive protein, and procalcitonin), ICU delirium, ICU sleep quality, and clinical outcomes (encompassing ICU mortality, in-hospital mortality, 28-day all-cause mortality, 90-day all-cause mortality, 90-day readmission rate, and 90-day incidence of secondary infections).
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
Wuhan, Hubei, 460022, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients received FMT via a nasojejunal tube in addition to standard ICU care. Specifically, 50-100 mL of intestinal microbiota suspension was administered daily via the nasojejunal tube between 11:00 and 13:00 for three consecutive days.
Time frame: 24, 48, 72, 96, and 120 hours after study enrollment
Time frame: 24-0 hours and 120 hours after study enrollment
Time frame: 24-0 hours and 120 hours after study enrollment
Time frame: 24-0 hours and 120 hours after study enrollment
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Time frame: 0 and 120 hours after study enrollment
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Time frame: Within 28 days after study enrollment
Time frame: Within 60 days after study enrollment
Time frame: Within 28 days after study enrollment
Time frame: Within 90 days after study enrollment
Time frame: Within 90 days after study enrollment
Time frame: Within 90 days after study enrollment
Contact information is provided by the study sponsor or research team.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Other
Fecal Microbiota Transplantation for Feeding Intolerance Due to Gastrointestinal Dysfunction in Critically Ill Patients: A Single-Center, Single-Blind, Randomized Controlled Trial
Acronym: FMT-FIT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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