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Clinical research on efficacy of fecal microbiota transplantation for lupus nephritis

Clinical research on efficacy of fecal microbiota transplantation for lupus nephritis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093470
Enrollment
Unknown
Registered
2024-12-05
Start date
2024-12-06
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

lupus nephritis

Interventions

experimental group:Fecal MicrobiotaTransplantation

Sponsors

The First Medical Center, Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age 18-70 years; Diagnosis in accordance with the diagnostic classification criteria for systemic lupus erythematosus (SLE) published jointly by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR) in 2019; Renal biopsy diagnosis of lupus nephritis; 24-hour urine protein quantification >0.5g; Anti-double-stranded DNA >= 77 IU/mL (ELISA) or >= 20 IU/mL (Farr) or complement C3 < 1.4 g/L, C4 < 0.4 g/L; Voluntarily accepting fecal microecological product transplantation therapy.

Exclusion criteria

Exclusion criteria: Malignant tumors; History of neuropsychiatric disorders and alcohol abuse; Patients who have used antibiotics within the last 1 week; Pregnant and lactating women; Concomitant serious diseases of other systems, such as severe hepatic insufficiency and cardiac insufficiency.

Design outcomes

Primary

MeasureTime frame
24-hour urine protein;blood albumin;glomerular filtration rate;

Secondary

MeasureTime frame
Adverse reactions and grading;blood creatinine;blood urea;C-reactive protein;Systemic Lupus Erythematosus Disease Activity Index (SLEDAI);The structural and quantity alterations of intestinal flora before and after fecal transplantation;

Countries

China

Contacts

Public ContactYang Yunsheng

The First Medical Center, Chinese PLA General Hospital

sunnyddc@plagh.org+86 10 5549 9305

Outcome results

None listed

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