Status:
COMPLETED
Effect of Fecal Capsule on Chronic Kidney Disease (CKD)
Lead Sponsor:
Shanxi Provincial People's Hospital
Conditions:
Renal Insufficiency, Chronic
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
By collecting blood, urine and stool samples before and after oral Enterobacteriaceae capsule (FMT) from CKD subjects, we investigated the role and related mechanisms of gut microecology in the develo...
Detailed Description
Patients involved in the trial received 16 capsules of Enterobacteriaceae (one course) on days 1, 8, and 15, which were provided by Dongyuan Yikang company. Patients were prohibited from taking antibi...
Eligibility Criteria
Inclusion
- Subjects: Patients with chronic kidney disease (CKD)
- GFR ≥ 30 ml / min, or serum creatinine ≤ 442 μ mol/L
- Negative urine pregnancy test and no plans for pregnancy for the next 18 months, enabling effective contraception
- Age: 18-70 years
- Signed informed consent for clinical studies informed consent for treatment of patients with flora transplantation (FMT)
Exclusion
- Had taken antibiotics for nearly 14 days
- Active systemic infections or severe infections within 1 month prior to enrollment, including HIV, HBV, HCV
- White blood cell count \< 3.0x109/l; Platelet count \< 80x109 / L, or had other hematologic diseases
- Presence of malignancy and other diseases with expected survival time \< 3 months
- Presence of IBD, CDI, or gastrointestinal tumors
- Presence of active gastrointestinal bleeding or acute and chronic gastrointestinal inflammation
- Were or had undergone FMT
- Psychosis and cognitive impairment
- History of alcohol or drug abuse
- Pregnant or lactating women
- Difficult to follow-up
- Difficult or unwilling to cooperate
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06166667
Start Date
March 1 2023
End Date
December 31 2023
Last Update
May 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanxi Provincial People's Hospita
Taiyuan, Shanxi, China, 030012