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Taking people in ChinaPhase 2

Tests oral stool-derived capsules for refractory rheumatoid arthritis

Tests capsules containing gut bacteria against placebo in adults with active refractory rheumatoid arthritis.

Key facts

Who runs it
Peking Union Medical College Hospital
Where
Beijing, ChinaSee the site
Trial code
Registry title
Faecal Microbiota Transplantation in Patients With Refractory Rheumatoid Arthritis
Status
Recruiting
Phase
Phase 2
People taking part
40 people, planned
Started
1 Jul 2026
Expected to end
31 Dec 2031
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • lyophilised oral capsules with faecal microbiota
  • Placebo capsules
Record updated
21 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18-65 with active rheumatoid arthritis that has not responded well to standard drugs, to test faecal microbiota capsules against placebo.

Age
18 to 65 years
Sex
Women and men can join.
Disease stage
Rheumatoid arthritis meeting the 2010 ACR/EULAR criteria, with active disease: at least 3 swollen joints, at least 3 tender joints, and raised blood inflammation tests (ESR above 25 mm/hr or hypersensitive C-reactive protein above 10 mg/L). Daily function must be class I, II or III.
Earlier treatment
Must have taken csDMARDs, including methotrexate at a stable dose of 7.5 - 20 mg/week, for 3 months or longer, and must be willing to continue them. Must not have used biologics or small-molecule targeted drugs in the last 6 months, nor oral or injected glucocorticoids in the last month.
Biomarker or test result
Positive RF or anti-CCP antibody at screening.

Main reasons for not taking part

  • Pregnant or breastfeeding
  • Another inflammatory rheumatic disease besides rheumatoid arthritis
  • Severe or uncontrolled disease of the heart, lungs, kidneys, liver, gut, blood, metabolism, hormones or nerves
  • Severe enteritis, bowel obstruction or bleeding, or past gut surgery
  • Active infection in the last 3 months or long-lasting infection such as HIV, HCV, HBV or tuberculosis; current or past cancer

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • Age 18-65 years with informed consent
  • Fulfill the 2010 ACR/EULAR classification criteria for rheumatoid arthritis
  • Positive RF or anti-CCP antibody on screening
  • Active disease status with swollen joint count(SJC)≥3 and tender joint count(TJC)≥3 and ESR >25 mm/hr or hypersensitive C-reactive protein > 10 mg/L
  • Having received csDMARDs including but not limited to methotrexate (at a stable dose of 7.5 - 20 mg/week) for 3 months or longer prior to screening and willing to continue current regimen for the duration of the study
  • Other csDMARDs (e.g. Leflunomide, Iguratimod, Sulfasalazine, Hydroxychloroquine, Tripterygium Wilfordii, etc.) taking before screening with dosage stablized for 3 months or longer are permitted and should continue during the duration of the study
  • Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA
  • If taking non-steroidal anti-inflammatory drugs (NSAIDs), must be at a stable dose for at least two weeks prior to screening
  • Female subjects must have a negative pregnancy test unless they are surgically sterile or have been post-menopausal for at least one year (12 consecutive months without menses)
  • Participants with fertility must use a medically effective form of contraception and agree to continue its use during the study or at least 3 monts after the last dose of study intervention
  • Willing to suspend the use of other adjuvant treatment for the duration of the study including acupuncture, massage, etc

Who cannot take part

  • Having used biologics or small-molecular targeting agents in 6 months prior to screening
  • Taking oral glucocorticoid (GC) or get GC injection (intra-articular or parenteral) in one month prior to screening
  • History of any inflammatory rheumatological disorders other than RA
  • Severe, progressive, or uncontrolled visceral disease including cardiac, pulmonary, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine or neurologic disease
  • Severe enteritis, intestinal obstruction or bleeding, or history of gastrointestinal surgery
  • Active infection in recent 3 months or persistent chronic infection, including HIV, HCV, HBV, tuberculosis
  • Malignancy or history of malignancy
  • Other conditions that investigators consider inappropriate for this study
  • Pregnant, lactating or further fertility requirements

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in China

  • Peking Union Medical College HospitalBeijing, ChinaContact: Lidan ZhaoTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • FMT groupTreatment being tested

    Participants of this group will take lyophilised oral capsules with faecal microbiota prepared from health donors; previous csDMARDs regimen will continue simutaneously.

    Treatment: lyophilised oral capsules with faecal microbiota

  • Placebo groupPlacebo, for comparison

    Participants in this group will take placebo capsules with no microbiota inside; previous csDMARDs regimen will continue simutaneously.

    Treatment: Placebo capsules

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Efficacy and Safety of Lyophilised Oral Faecal Microbiota Transplantation in Patients With Active Refractory Rheumatoid Arthritis- A Randomized Controlled Study
Plain-language title
Tests oral stool-derived capsules for refractory rheumatoid arthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07639177, who can take part
Record updated
21 September 2026