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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06641778
Enrollment
100
Registered
2024-10-15
Start date
2024-12-03
Completion date
2026-09-30
Last updated
2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Klebsiella Pneumoniae Pneumonia

Keywords

Fecal Microbiota Transplantation, Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia

Brief summary

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.

Detailed 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.

Interventions

OTHERFecal 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

Sponsors

luxia Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of days MDR-KP turns negativeone monthThe number of days that multidrug-resistant Klebsiella pneumoniae turned negative after treatment
Length of hospital stayone monthTotal length of stay from admission to discharge or death
mortality rateone monthThe ratio of death cases to the total number of patients

Secondary

MeasureTime frameDescription
The Incidence of feverone monthThe incidence of fever in patients was included
The incidence of chest pain assessed by VASone monthThe incidence of chest pain in patients was included
The incidence of coughone monthThe incidence of cough in patients was included
The incidence of phlegmone monthThe incidence of phlegm in patients was included

Countries

China

Contacts

Primary ContactLuxia Kong, master
510229519@qq.com17671460541
Backup ContactShuang Geng, doctor
027-82223802

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026