Fecal microbiota transplantation for treating drug-resistant pneumonia
Official title: Fecal Microbiota Transplantation in Patients With Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia
Run by Wuhan Central Hospital · NCT06641778 · Data updated 2026-11-12
This study is testing if adding a fecal transplant to regular antibiotic treatment can help people with drug-resistant pneumonia feel better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Wuhan Central Hospital Academic / other |
| Drugs / interventions | rituximab, doxorubicin |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | December 3, 2024 |
| Main results expected | March 31, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | December 3, 2024 |
| Trial ID | NCT06641778 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-75 diagnosed with community-acquired or hospital-acquired pneumonia caused by multidrug-resistant Klebsiella pneumoniae.
✕Probably not a fit
Patients with severe pulmonary dysfunction, persistent bronchial asthma, or significant gastrointestinal issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the use of fecal microbiota transplantation (FMT) as a treatment for patients suffering from multidrug-resistant Klebsiella pneumoniae pneumonia. Participants are randomly assigned to receive either conventional antibiotic treatment alone or conventional treatment combined with FMT. The study aims to compare clinical symptoms, inflammatory and immune responses, and changes in intestinal and respiratory microbiomes between the two groups. By exploring the therapeutic potential of FMT, the study seeks to address the challenges posed by antibiotic resistance in pneumonia cases.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with multidrug-resistant pneumonia.
How similar studies have gone: While fecal microbiota transplantation has shown promise in treating various conditions, its application for multidrug-resistant pneumonia is relatively novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75; * Meet the diagnostic criteria for community-acquired pneumonia or hospital-acquired pneumonia; * The etiological results of sputum or alveolar lavage fluid suggested MDR-KP infection; * The patient or his family members voluntarily participated, collected alveolar lavage fluid and stool samples, agreed to perform FMT treatment, and signed the informed consent. Exclusion Criteria: * Subjects with persistent bronchial asthma, severe pulmonary dysfunction, or inability to tolerate bronchoscopy; * Patients with severe damage of intestinal barrier such as sepsis and digestive tract perforation due to various reasons; * Those currently diagnosed with explosive colitis or toxic megacolon have gastroesophageal reflux disease or peptic ulcer; Subjects taking probiotics within 6 months; * Enteral nutrition patients who could not tolerate 50% of heat calorie requirements due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high-flow intestinal fistula and other reasons. * Patients with obvious bleeding tendency, severe pulmonary hypertension, superior vena cava obstruction, and aortic aneurysm rupture risk; * Patients with malignant hypertension, recent myocardial infarction (≤6 months), severe arrhythmia, and cardiac insufficiency; * suffering from malignant tumor diseases, congenital or acquired immune deficiency diseases, other systemic inflammatory response diseases; * Those who have recently been treated with high-risk immunosuppressive/cytotoxic drugs, such as rituximab, doxorubicin, or steroid hormones (20mg/d ponisone or higher) for more than 4 weeks; * Severe immunosuppression: adult neutrophils \<1 500/mm3, child neutrophils \<1 000/mm3; * Pregnancy or lactation; * There is a mental disability or active mental illness that prevents informed consent; * Conditions deemed unsuitable for study inclusion by other clinicians.
Where it's running
-
The central Hospital of Wuhan
Wuhan, Hubei, China Recruiting
Study contacts
- Study coordinator: Luxia Kong, master
- Email: 510229519@qq.com
- Phone: 17671460541
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Prevalence and resistance patterns of Klebsiella pneumoniae in the respiratory ICU
This study tests how common Klebsiella pneumoniae is in respiratory samples from adults in the respiratory ICU and describes their antibiotic resistance and related clinical features.
-
Phase 1 dose-finding test of a bivalent Klebsiella pneumoniae vaccine in healthy adults
This study will test a bivalent Klebsiella pneumoniae vaccine in healthy adults aged 18–50 to see if it is safe and triggers an immune response.
-
Comparing a placebo to an antibiotic for pneumonia in children
This study is testing if an antibiotic called azithromycin helps children aged 3-17 with pneumonia caused by Mycoplasma pneumoniae get better faster than a placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.