The Effects of Fecal Microbiota Transplantation on Intestinal Microbiota and Pulmonary Microecology in Critically Ill Patients With Multidrug-Resistant Organisms (MDROs) Infections: A Single-Center, Open-Label, Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

At present, carbapenem-resistant Enterobacteriaceae (CROs) infections are a global challenge. The use of antibiotics, proton pump inhibitors, and vasoconstrictors in the intensive care unit (ICU), as well as the disease state, have a significant impact on the intestinal flora and may also have a significant impact on the pulmonary microecology, which is unfavorable for the long-term prognosis of patients. The study of pulmonary microecology is currently a hot topic, but it is not clear whether intestinal flora disorders promote pulmonary microecological disorders. Therefore, it is also unclear whether intestinal flora disorders in patients with severe CRO infections have an impact on pulmonary microecological disorders. This project aims to first study the differences in intestinal flora and pulmonary microecology between patients with pulmonary CRO infections and those without CRO infections, as well as the correlation between intestinal flora disorders and pulmonary microecology. Fecal microbiota transplantation (FMT) is a therapeutic approach that involves transplanting the functional intestinal microbiota from healthy individuals into patients to restore an imbalanced intestinal microbiota and treat intestinal and extra-intestinal diseases. Studies have shown that FMT has a positive effect on the clearance of CROs colonization and the prevention of infection in non-ICU patients. Over the past decade, FMT has made breakthrough progress in the treatment of intestinal and extra-intestinal diseases, bringing disruptive new strategies for the treatment of difficult intestinal and extra-intestinal diseases. These results suggest that FMT not only helps to restore a healthy intestinal microbiota but may also reduce the occurrence of recurrent infections by inhibiting the competition of drug-resistant bacteria. Given that CROs in the intestinal microbiota are an important source of enterogenic infections and hospital-acquired bloodstream infections and pneumonia, this project aims to further conduct a randomized controlled clinical study, including critically ill patients with MDROs infections admitted to the ICU, who can be evaluated to discontinue antibiotics and have food intolerance syndrome. FMT will be administered through a nasojejunal tube to improve the imbalance of the intestinal microbiota caused by broad-spectrum antibiotics and other disturbances, and to study the promoting effect and safety of FMT on the recovery of pulmonary microecological imbalance in critically ill patients, as well as to evaluate its impact on ICU stay, ICU mortality, in-hospital mortality, and 28-day mortality.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age ranging from 18 to 70 years old;

• ICU patients. Gender and ethnicity are not restricted;

• Informed consent obtained.

• Patients who have been admitted to the ICU for at least 24 hours;

• An anticipated ICU stay of at least 7 days following enrollment in the study;

• Diagnosed with food intolerance syndrome.

Locations
Other Locations
China
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Jiancheng Zhang
zhjcheng1@126.com
13554105815
Time Frame
Start Date: 2025-05-20
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 150
Treatments
Experimental: FMT intervention group
On the basis of the standard intensive care unit (ICU) treatment protocol, fecal microbiota transplantation (FMT) was administered via a nasojejunal tube. Over three consecutive days, 100 ml of intestinal flora suspension was delivered through the nasojejunal tube daily between 11:00 and 13:00.
No_intervention: Control group
Receiving the standard ICU treatment protocol involves a comprehensive set of systematic and standardized medical and nursing interventions designed for critically ill patients in the ICU. These interventions are aimed at ensuring patient stability through multidisciplinary collaboration, continuous physiological monitoring, and functional support, while also facilitating recovery. The ICU treatment protocol is developed based on modern medical principles and extensive clinical experience, encompassing all aspects from fundamental care to advanced life support.
Related Therapeutic Areas
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

This content was sourced from clinicaltrials.gov