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A Clinical Study on the Efficacy and Safety of Fecal Microbiota Transplantation for Treating Carbapenem-Resistant Klebsiella pneumoniae Infection

A Clinical Study on the Efficacy and Safety of Fecal Microbiota Transplantation for Treating Carbapenem-Resistant Klebsiella pneumoniae Infection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100923
Enrollment
Unknown
Registered
2025-04-17
Start date
2025-05-15
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Carbapenem-Resistant Klebsiella pneumoniae Infectio

Interventions

Fecal microbiota transplantation group:Fecal microbiota transplantation is performed once every other day for three times.
Standard treatment group:Antibiotic treatment

Sponsors

The First People's Hospital of Yunnan Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adult patients (>=18 years of age at enrollment) 2. Patients received positive CRKP from rectal swabs within 1 week before the trial. 3. Participants or legal representatives must be able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Life expectancy is three months or less. 2. Pregnancy or lactation. 3. Patients who are unable/unwilling to participate in the study. 4. History of colectomy, colostomy or ileostomy. 5. Severe immunodeficiency (1) Systemic chemotherapy = 60 mg/day for >=30 days) or other immunosuppressive drugs (4) Neutropenia, absolute neutrophil count <1000/µL, (5) Solid organ transplant recipients (6) Recipients of hematopoietic stem cell transplantation (7) Other causes of severe immunodeficiency. 6. Clinical symptoms and signs of mucositis. 7. Major abdominal surgery within the upcoming 30 days. 8. Severe drug or food allergies. 9. Anatomical contraindications for nasogastric tube placement. 10. Unable to obtain a compatible FMT preparation (regarding donor/recipient CMV, EBV and toxoplasmosis serology). 11. Judged by the investigator as not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Clearance of carbapenem-resistant Klebsiella pneumoniae;

Secondary

MeasureTime frame
Improvement of carbapenem-resistant Klebsiella pneumoniae infection.;

Countries

China

Contacts

Public ContactChen Guobing

The First People's Hospital of Yunnan Province

rocktom38chen@163.com+86 158 0885 5293

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026