Effect of Fecal Capsule on Chronic Kidney Disease (CKD)

Not Applicable

Completed

• Conditions: Renal Insufficiency, Chronic
• Interventions: Procedure: Fecal Microbiota Transplant（FMT）

• Registration Number: NCT06166667
• Lead Sponsor: Shanxi Provincial People's Hospital

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.

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-05-06
• Study First Submitted QC: 2023-12-03
• Study First Posted: 2023-12-12
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	Fecal Microbiota Transplant（FMT）	Fecal Microbiota Transplant

Primary Outcome Measures

Name	Time	Method
Abundance of gut microbiota	6 months after the end of the trial	Fecal sample metagenomic sequencing

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shanxi Provincial People's Hospita; 🇨🇳 Taiyuan, Shanxi, China