The Effects of FMT on Intestinal Microbiota and Pulmonary Microecology

Launched by WUHAN UNION HOSPITAL, CHINA · May 5, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of fecal microbiota transplantation (FMT) on patients with serious lung infections caused by drug-resistant bacteria known as carbapenem-resistant Enterobacteriaceae (CROs). The study aims to understand how the balance of bacteria in the gut (intestinal microbiota) affects the bacteria in the lungs (pulmonary microecology). Researchers want to find out if restoring a healthy gut microbiota through FMT can help improve lung health and overall recovery in critically ill patients.

To be eligible for this trial, participants need to be between 18 and 70 years old, currently staying in the ICU for at least 24 hours, and expected to remain in the ICU for a minimum of 7 days. They should also have a condition known as food intolerance syndrome. Participants will receive FMT through a tube placed in their intestine, and the study will monitor its safety and impact on their recovery, including how long they stay in the ICU and their chances of survival. This trial hopes to provide new insights into treating severe infections and improving patient outcomes in the hospital setting.

Gender

ALL

Eligibility criteria

• • The initial step involves investigating the alterations in pulmonary and intestinal microbiota among ICU patients infected with CROs, as well as the correlation between these changes.
• Inclusion Criteria:
• • 1. Age ranging from 18 to 70 years old;
• • 2. ICU patients. Gender and ethnicity are not restricted;
• • 3. Informed consent obtained.
• Exclusion Criteria:
• • 1. Airway antibiotics (administered via nebulization or intravenous infusion) have been utilized since the current hospitalization;
• • 2. Pulmonary infection caused by non-bacterial pathogens, such as viruses, fungi, or atypical organisms;
• • 3. Infections located outside the pulmonary system, including those in the bloodstream, abdominal cavity, or urinary tract;
• • 4. Respiratory failure secondary to non-pulmonary infections, such as cardiogenic factors or sepsis-like syndromes;
• • 5. Chronic pulmonary conditions, including chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, and pulmonary interstitial fibrosis;
• • 6. Chronic gastrointestinal disorders, such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease, and non-alcoholic fatty liver disease (NAFLD);
• • 7. Recent surgical procedures involving the abdomen or lungs (within 14 days prior to admission);
• • 8. Pregnant or breastfeeding individuals;
• • 9. Participation in other clinical trials within three months prior to enrollment;
• • 10. Lack of a signed written informed consent form.
• • Based on the inclusion and exclusion criteria of the first step of the study, further screening was conducted to investigate the promoting effect and safety of fecal microbiota transplantation (FMT) on the recovery of pulmonary microecological imbalance in critically ill patients, and to evaluate its impact on the length of stay in the intensive care unit (ICU), ICU mortality, in-hospital mortality, and 28-day mortality, etc.
• Inclusion Criteria:
• • 1. Patients who have been admitted to the ICU for at least 24 hours;
• • 2. An anticipated ICU stay of at least 7 days following enrollment in the study;
• • 3. Diagnosed with food intolerance syndrome.
• Exclusion Criteria:
• • 1. Severe systemic infection during the early resuscitation phase, characterized by hemodynamic instability, inadequate tissue perfusion, or severe water, electrolyte, and acid-base imbalance;
• • 2. Patients identified by clinicians as having a high risk of death within 5 days or those subject to restricted treatment decisions;
• • 3. Significant intestinal barrier compromise due to conditions such as active gastrointestinal hemorrhage or perforation;
• • 4. Patients receiving enteral nutrition who are unable to tolerate 50% of their caloric requirements due to significant fibrotic intestinal stenosis, high-output enteric fistulae, or other reasons;
• • 5. Planned abdominal surgery within 14 days;
• • 6. Individuals currently diagnosed with fulminant colitis or toxic megacolon;
• • 7. Neutropenia (neutrophil count \< 1500 cells/µL);
• • 8. Patients with congenital or acquired immunodeficiency disorders;
• • 9. Autoimmune diseases;
• • 10. Hematological malignancies;
• • 11. Individuals who have recently undergone treatment with high-risk immunosuppressive or cytotoxic agents, including rituximab, doxorubicin, or medium-to-high dose steroid hormones (e.g., prednisone ≥ 20 mg/day for more than 4 weeks).