Fecal microbiota transplantation in the treatment of active systemic lupus erythematosus

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000036352

Enrollment

Unknown

Registered

2020-08-22

Start date

2020-08-18

Completion date

Unknown

Last updated

2022-01-24

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

Conditions

Systemic Lupus Erythematosus

Interventions

Case series:Fecal microbiota transplantation (FMT) capsules

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged between 18-65 years old; 2. Patients fulfilled 2019 EULAR/ACR classification criteria for SLE; 3. SLEDAI-2K score >= 6 at screening; 4. Patients have received one or more of the following systemic standard treatments: 1) Oral corticosteroids for more than 8 weeks,and stable dose for more than 4 weeks; 2) hydroxychloroquine(200-400mg/d) for more than 8 weeks,and stable dose for more than 6 weeks; 3) One or more of the immunosuppressant agent for more than 12 weeks,and stable dose for more than 6 weeks.If the subjects received more than two of the above immunosuppressant agent, discussion with the researchers for the appropriateness of their participation in the study is required. 5. Patient with good compliance, sign the informed consent before the study.

Exclusion criteria

Exclusion criteria: (1) Patients with severe active lupus nephritis; (2) Patients with central nervous system diseases; (3) Patients with malignant tumors; (4) Patients with other inflammatory or autoimmune diseases; (5) Patients with severe heart, liver and kidney diseases and disease history of important organs, blood and endocrine system; (6) Participate in other clinical trials within three months. (7) Antimicrobial agents, probiotics / probiotics and other drugs that had great influence on intestinal microbiota within 2 months; (8) Active or recurrent severe infection; (9) Immunodeficiency or immunocompromised; (10) Pregnant and lactating women; (11) The investigator considered it inappropriate to participate in this study.

Design outcomes

Primary

Measure	Time frame
Responder Index-4 (SRI-4);	—

Secondary

Measure	Time frame
SLEDAI-2K;Decreased glucocorticoid dose;Peripheral blood lymphocyte subsets;Clinical symptoms and organ involvement;Time to first relapse;Laboratory testing;	—

Countries

China

Contacts

Public ContactQianjin Lu

The Second Xiangya Hospital of Central South University

qianlu5860@gmail.com+86 13787097676

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026