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Fecal Microbiota Transplantation in Patients With Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia

Fecal Microbiota Transplantation in Patients With Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia

Recruiting
18-75 years
All
Phase N/A

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Overview

Multidrug-resistant Klebsiella pneumoniae (MDR-KP) infections account for 10% of all nosocomial infections, and even with effective antibiotics, the mortality rate is as high as 50%. Intestinal bacteria transplantation can not only treat intestinal diseases, but also inhibit the colonization and proliferation of drug-resistant bacteria. This study explored the therapeutic value of fecal microbiota transplantation in patients with MDR-KP pneumonia.

Description

Intervention study (controlled clinical study) : patients with multidrug-resistant Klebsiella pneumoniae pneumonia were randomly assigned to the experimental group (conventional antibiotic treatment + fecal microbiota transplantation) and the control group (conventional antibiotic treatment); The clinical symptoms, inflammatory indexes, immune indexes, intestinal microecology, respiratory microecology and antibiotic resistance gene changes were compared between the two groups.

Eligibility

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.

Study details
    Klebsiella Pneumoniae Pneumonia

NCT06641778

luxia Kong

16 October 2025

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