Fecal Microbiota Transplantation in Patients With Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia
NCT ID: NCT06641778
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-12-03
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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experimental group
This group of patients received conventional antibiotic therapy and fecal microbiota transplantation.
Fecal Microbiota Transplantation
Patients in the experimental group received conventional antibiotic therapy plus fecal microbiota transplantation, and the efficacy was compared with that in the control group
control group
Patients in this group were treated with conventional antibiotics.
No interventions assigned to this group
Interventions
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Fecal Microbiota Transplantation
Patients in the experimental group received conventional antibiotic therapy plus fecal microbiota transplantation, and the efficacy was compared with that in the control group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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luxia Kong
OTHER
Responsible Party
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luxia Kong
physician
Principal Investigators
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Shuang Geng
Role: STUDY_DIRECTOR
Wuhan Central Hospital
Locations
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The central Hospital of Wuhan
Wuhan, Hubei, China
Countries
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Central Contacts
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Shuang Geng, doctor
Role: CONTACT
Facility Contacts
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Other Identifiers
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LXKong
Identifier Type: -
Identifier Source: org_study_id