Effect of Fecal Capsule on Chronic Kidney Disease (CKD)

NCT06166667 | Completed DMC

• 1 other identifier: (2022) SYKLSZ No.352
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

• Abundance of gut microbiota

  Fecal sample metagenomic sequencing

  6 months after the end of the trial

Secondary Outcomes (3)

• 24-hour urine protein quantitative change rate

  6 months after the end of the trial

• the density of immune cells

  6 months after the end of the trial

• Cytokine concentration

  6 months after the end of the trial

Study Arms (1)

experimental group

EXPERIMENTAL

Fecal Microbiota Transplant

Procedure: Fecal Microbiota Transplant（FMT）

Interventions

Fecal Microbiota Transplant（FMT） PROCEDURE

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.

experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanxi Provincial People's Hospital: lead

Study Sites (1)

Shanxi Provincial People's Hospita

Taiyuan, Shanxi, 030012, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yafeng Li, Professor

  Shanxi Provincial People's Hospital (Fifth Hospital) of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: December 12, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the study is completed
• Access Criteria: Nephrologist

Locations

CN (1)