Effect of Fecal Capsule on Chronic Kidney Disease (CKD)

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Insufficiency, Chronic
• Intervention / Treatment: Procedure: Fecal Microbiota Transplant（FMT）

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenqiang Zhi, Doctor; Phone Number: 15034402503; Email: wenqiangz0122@163.com

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030012
      • Recruiting
      • Shanxi Provincial People's Hospita
      • Contact: Wenqiang Zhi, postgraduate; Phone Number: 15034402503; Email: wenqiangz0122@163.com
      • Contact: Ya-feng Li, Professor; Phone Number: 13935151151; Email: Dr.yafengli@gmail.com
      • Sub-Investigator: Wenqiang Zhi, postgraduate
      • Principal Investigator: Ya-feng Li, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Fecal Microbiota Transplant	Procedure: Fecal 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanxi Provincial People's Hospital
• Investigators: Principal Investigator: Yafeng Li, Professor, Shanxi Provincial People's Hospital (Fifth Hospital) of Shanxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: May 6, 2023
• First Submitted That Met QC Criteria: December 3, 2023
• First Posted (Estimated): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 3, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: (2022) SYKLSZ No.352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the study is completed，ResMan,http://www.medresman.org.cn
• IPD Sharing Time Frame: After the study is completed
• IPD Sharing Access Criteria: Nephrologist
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No