Effect of Fecal Capsule on Chronic Kidney Disease (CKD)

Shanxi Provincial People's Hospital

Status: Completed

Conditions: Renal Insufficiency, Chronic

Treatments: Procedure: Fecal Microbiota Transplant（FMT）

Study type: Interventional

Funder types: Other

Identifiers

NCT06166667

(2022) SYKLSZ No.352

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

experimental group

Experimental group

Description:

Fecal Microbiota Transplant

Treatment:

Procedure: Fecal Microbiota Transplant（FMT）