Faecal Microbiota Transplantation in Patients With Refractory Rheumatoid Arthritis

Sponsor
Peking Union Medical College Hospital
Study ID
NCT07639177
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • lyophilised oral capsules with faecal microbiota — DRUG
    Faecal microbiota is extracted from fresh stool collected from strictly screened health donors with canonical procedure, and then lyophilised and prepared into oral capsule.
  • Placebo capsules — DRUG
    placebo capsules with the same appearance as FMT capsules but no microbiota inside

Study Details

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.

Key Dates

First listed
Jun 10, 2026
Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FMT group
    Participants of this group will take lyophilised oral capsules with faecal microbiota prepared from health donors; previous csDMARDs regimen will continue simutaneously.
  • Placebo Comparator: Placebo group
    Participants in this group will take placebo capsules with no microbiota inside; previous csDMARDs regimen will continue simutaneously.

Primary Outcome Measure

ACR 20/50 response rates at 16 weeks [ Time Frame: week 16 ]

Central Contacts

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