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Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06970262

Study of Fecal Microbiota Transplantation to Improve Survival in Adults with Multidrug-Resistant Organism Lung Infection on Mechanical Ventilation

Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-08-03

60

Participants Needed

1

Research Sites

6 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the effects of fecal microbiota transplantation FMT on adults with multidrug-resistant organism MDRO infections who are mechanically ventilated in the intensive care unit ICU. The study aims to understand whether restoring gut microbial balance can reduce 28-day mortality and improve lung microbial health in critically ill patients. This trial addresses the connection between gut dysbiosis and lung microbial imbalance in MDRO-infected patients, a relationship not yet fully understood. Participants will be randomly assigned to receive either standard ICU care or standard care plus FMT administered through a nasojejunal tube. The FMT treatment involves daily delivery of 50-100 ml of intestinal flora suspension over three consecutive days. Standard ICU care includes a range of medical and nursing interventions, with restrictions on certain antibiotics to avoid disrupting gut bacteria. Both groups follow antibiotic guidelines to ensure comparable infection treatment. During the study, participants will undergo various assessments including monitoring of organ function scores, lung and gut microbiota diversity, serum metabolites, and mortality rates at different time points up to 90 days. Researchers will track changes before and after FMT treatment and evaluate correlations between gut and lung microbial communities. The study will last until December 2027, with primary evaluation of mortality at 28 days and extended follow-ups for hospital and ICU outcomes.

CONDITIONS

Brief Title

FMT for Lung and Associated-organ Rescue Efficacy in MDRO-infected Ventilated Patients

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 70 years, any sex or ethnic background
  • Admission to intensive care unit (ICU) within 24 to 48 hours
  • Expected ICU stay of at least 7 days as assessed by the ICU doctor
  • Mechanically ventilated patients with multidrug-resistant organism (MDRO) infection
  • Written informed consent provided by participant or legal representative
Not Eligible

You will not qualify if you...

  • Severe systemic infection with unstable blood flow or life-threatening electrolyte or acid-base problems
  • High risk of death within 5 days or do-not-resuscitate/do-not-intubate orders
  • Active gastrointestinal bleeding or perforation indicating severe intestinal damage
  • Unable to tolerate enteral nutrition providing at least 50% of calories due to bowel problems
  • Planned or recent abdominal surgery within 14 days before enrollment
  • Fulminant colitis or toxic megacolon diagnosis
  • Neutropenia with low neutrophil count below 1.5 x 10^9/L
  • Recent use of strong immunosuppressive or cytotoxic drugs within the last 3 months
  • Pregnancy or breastfeeding
  • Participation in another interventional clinical trial within 3 months before or during this study

Research Team

J

Jiancheng Zhang

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