Renal Insufficiency, Chronic
Conditions
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 development of CKD using a combination of metagenomic sequencing, metabolomic analysis and flow cytometry.
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 antibiotics such as amoxicillin and Cefalexin during the trial.
Interventions
PROCEDUREFecal Microbiota Transplant（FMT）
Patients involved in the trial received 20 capsules of Enterobacteriaceae (one course) on days 1, 8, and 15, which were provided by Dongyuan Yikang company. Patients were prohibited from taking antibiotics such as amoxicillin and Cefalexin during the trial.
Sponsors
Shanxi Provincial People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects: Patients with chronic kidney disease (CKD) 2. GFR ≥ 30 ml / min, or serum creatinine ≤ 442 μ mol/L 3. Negative urine pregnancy test and no plans for pregnancy for the next 18 months, enabling effective contraception 4. Age: 18-70 years 5. Signed informed consent for clinical studies informed consent for treatment of patients with flora transplantation (FMT)
Exclusion criteria
1. Had taken antibiotics for nearly 14 days 2. Active systemic infections or severe infections within 1 month prior to enrollment, including HIV, HBV, HCV 3. White blood cell count \< 3.0x109/l; Platelet count \< 80x109 / L, or had other hematologic diseases 4. Presence of malignancy and other diseases with expected survival time \< 3 months 5. Presence of IBD, CDI, or gastrointestinal tumors 6. Presence of active gastrointestinal bleeding or acute and chronic gastrointestinal inflammation 7. Were or had undergone FMT 8. Psychosis and cognitive impairment 9. History of alcohol or drug abuse 10. Pregnant or lactating women 11. Difficult to follow-up 12. Difficult or unwilling to cooperate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abundance of gut microbiota | 6 months after the end of the trial | Fecal sample metagenomic sequencing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour urine protein quantitative change rate | 6 months after the end of the trial | Urine sample |
| the density of immune cells | 6 months after the end of the trial | Blood samples |
| Cytokine concentration | 6 months after the end of the trial | Blood samples |
Countries
China
Outcome results
None listed