Effect of Fecal Capsule on Chronic Kidney Disease (CKD)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Fecal Capsule on Chronic Kidney Disease (CKD)

Conditions
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Renal Insufficiency, Chronic

Intervention / Treatment
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* Procedure: Fecal Microbiota Transplant（FMT）


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Fecal Microbiota Transplant | Procedure: Fecal Microbiota Transplant（FMT）<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abundance of gut microbiota | Fecal sample metagenomic sequencing | 6 months after the end of the trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour urine protein quantitative change rate | Urine sample | 6 months after the end of the trial | 
| the density of immune cells | Blood samples | 6 months after the end of the trial | 
| Cytokine concentration | Blood samples | 6 months after the end of the trial |