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Effect of fecal capsule on chronic kidney disease (CKD)

Effect of fecal capsule on chronic kidney disease (CKD)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067233
Enrollment
Unknown
Registered
2022-12-30
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease (CKD)

Interventions

Experimental group:Fecal Microbiota Transplant

Sponsors

Shanxi Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Subjects: patients with chronic kidney disease (CKD); 2. GFR>=30ml/min, or serum creatinine <=442µmol/L; 3. A negative urine pregnancy test, no pregnancy plans in the next 18 months, and able to take effective contraceptive measures; 4. Aged 18-70 years; 5. Signed informed consent for clinical study and informed consent for bacterial transplantation (FMT) treatment.

Exclusion criteria

Exclusion criteria: 1. Have taken antibiotics in the last 14 days; 2. Active systemic infections or severe infections within 1 month prior to enrollment, including HIV, HBV and HCV; 3. White blood cell count <3.0x10^9/L; Platelet count <80X10^9/L, or other blood system diseases; 4. Malignant tumors and other diseases exist, and the expected survival time is less than 3 months; 5. The presence of IBD, CDI, or digestive tract tumors; 6. Active gastrointestinal bleeding or acute and chronic gastrointestinal inflammation; 7. Receiving or has received FMT; 8. Mental illness and cognitive impairment; 9. History of alcohol or drug abuse; 10. Pregnant or lactating patients; 11. Difficult to follow; 12. Patients who are difficult or unwilling to cooperate.

Design outcomes

Primary

MeasureTime frame
Gut flora;

Secondary

MeasureTime frame
Routine blood test;Liver and kidney function;Immune cell;Cytokine;Routine urine test;24-hour urine protein quantification;Urine specific protein;

Countries

China

Contacts

Public ContactLi Yafeng

Shanxi Provincial People's Hospital

dr.yafengli@gmail.com+86 13935151151

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026