Faecal Microbiota Transplantation in Patients With Refractory Rheumatoid Arthritis
NCT07639177 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-06-10
Summary
In this 24-week, single center, randomized, double-blind, placebo-controlled study, the efficacy and safety of lyophilised oral fecal microbiota transplantation in patients with active refractory rheumatoid arthritis will be evaluated.
Conditions
Interventions
- DRUG
-
lyophilised oral capsules with faecal microbiota
Faecal microbiota is extracted from fresh stool collected from strictly screened health donors with canonical procedure, and then lyophilised and prepared into oral capsule.
- DRUG
-
Placebo capsules
placebo capsules with the same appearance as FMT capsules but no microbiota inside
Sponsors & Collaborators
-
Qingdao Haier Biotech Co., LTD
collaborator UNKNOWN -
Peking Union Medical College Hospital
lead OTHER
Principal Investigators
-
Lidan Zhao · Peking Union Medical College Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-15
- Primary Completion
- 2028-06-01
- Completion
- 2028-12-31
Countries
- China
Study Locations
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