Effect of Fecal Capsule on Chronic Kidney Disease (CKD)

Renal Insufficiency, Chronic Clinical Trial

Official title:

Effect of Fecal Capsule on Chronic Kidney Disease (CKD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06166667
• Other study ID #: (2022) SYKLSZ No.352
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2023
• Source: Shanxi Provincial People's Hospital
• Contact: Wenqiang Zhi, Doctor
• Phone: 15034402503
• Email: wenqiangz0122[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
China	Shanxi Provincial People's Hospita	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Shanxi Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abundance of gut microbiota	Fecal sample metagenomic sequencing	6 months after the end of the trial
Secondary	24-hour urine protein quantitative change rate	Urine sample	6 months after the end of the trial
Secondary	the density of immune cells	Blood samples	6 months after the end of the trial
Secondary	Cytokine concentration	Blood samples	6 months after the end of the trial