Investigating the effects of fecal microbiota transplantation on lung and gut bacteria in ICU patients

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

This study is testing whether a treatment that involves transferring healthy gut bacteria can help improve lung health in ICU patients who have tough infections.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Wuhan Union Hospital, China (Academic / other)
• Drugs / interventions: rituximab, doxorubicin, prednisone
• Locations: 1 site (Wuhan)
• Trial ID: NCT06970262 on ClinicalTrials.gov

What this trial studies

This study examines the relationship between intestinal microbiota and pulmonary microecology in ICU patients suffering from carbapenem-resistant Enterobacteriaceae infections. It aims to identify differences in gut flora between patients with and without these infections and explore how these differences may influence lung health. The intervention involves administering fecal microbiota transplantation to assess its effects on both intestinal and pulmonary microbiota. The study will help clarify the potential link between gut health and lung infections in critically ill patients.

Who should consider this trial

Good fit: Ideal candidates are ICU patients aged 18 to 70 years who are infected with carbapenem-resistant Enterobacteriaceae.

Not a fit: Patients with pulmonary infections caused by non-bacterial pathogens or those with chronic pulmonary conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for lung infections by addressing underlying gut microbiota imbalances.

How similar studies have performed: While the study explores a relatively novel approach, previous research has indicated potential benefits of fecal microbiota transplantation in various infections, suggesting a promising avenue for investigation.

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).

Where this trial is running

Wuhan

• Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (Recruiting)

Study contacts

• Study coordinator: Jiancheng Zhang

Conditions Lung Infection; Microbial Colonization; Food Intolerance Syndromes