Faecal Microbiota Transplantation in Patients With Refractory Rheumatoid Arthritis

NCT07639177 | Not Yet Recruiting Phase 2

• 1 other identifier: JS-3013
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Rheumatoid Arthritis

Keywords

Faecal Microbiota Transplantation; Refractory Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• ACR 20/50 response rates at 16 weeks

  at week 16, the difference in ratio of participants who achieve ACR 20/50 response in two groups.

  week 16

Secondary Outcomes (7)

• ACR70 response at 16 weeks

  week 16

• ACR20/50/70 response at 24 weeks

  week 24

• DAS 28 (CRP) and DAS 28 (ESR) at 16 and 24 weeks

  week 16 and week 24

• EULAR response rates at 16 and 24 weeks;

  week 16 and week 24

• Health assessment questionnaire (HAQ) at 16 and 24 weeks;

  week 16 and week 24

Study Arms (2)

FMT group

EXPERIMENTAL

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

Drug: lyophilised oral capsules with faecal microbiota

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo capsules

Interventions

Placebo capsules DRUG

placebo capsules with the same appearance as FMT capsules but no microbiota inside

Placebo group

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.

FMT group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant, lactating or further fertility requirements
• History of any inflammatory rheumatological disorders other than RA;
• 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;
• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Qingdao Haier Biotech Co., LTD: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lidan Zhao

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lidan Zhao

CONTACT

13810700035; zhaolidan@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

CN (1)