Poop pills could tame stubborn arthritis
NCT ID NCT07639177
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether freeze-dried fecal bacteria, given as oral capsules, can improve symptoms in 40 adults with active rheumatoid arthritis that hasn't responded to standard drugs. Participants will receive either the fecal transplant or a placebo for 24 weeks. The main goal is to see if more people in the treatment group achieve at least a 20% or 50% improvement in arthritis symptoms by week 16.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lyophilised oral faecal microbiota (fecal transplant capsules)
- What this could lead to
- If it works, this could offer a new treatment option for people with rheumatoid arthritis that hasn't responded to standard medications.
- What could go wrong
- This is a small, early-phase trial with only 40 participants. The treatment may not work better than placebo, and long-term safety is unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jun 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-65 years with informed consent; 2. Fulfill the 2010 ACR/EULAR classification criteria for rheumatoid arthritis; 3. Positive RF or anti-CCP antibody on screening; 4. 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; 5. 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; 6. 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; 7. Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA; 8. If taking non-steroidal anti-inflammatory drugs (NSAIDs), must be at a stable dose for at least two weeks prior to screening; 9. 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) ; 10. 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. 11. Willing to suspend the use of other adjuvant treatment for the duration of the study including acupuncture, massage, etc. Exclusion Criteria: 1. Pregnant, lactating or further fertility requirements 2. History of any inflammatory rheumatological disorders other than RA; 3. Having used biologics or small-molecular targeting agents in 6 months prior to screening; 4. Taking oral glucocorticoid (GC) or get GC injection (intra-articular or parenteral) in one month prior to screening; 5. Severe, progressive, or uncontrolled visceral disease including cardiac, pulmonary, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine or neurologic disease; 6. Severe enteritis, intestinal obstruction or bleeding, or history of gastrointestinal surgery. 7. Active infection in recent 3 months or persistent chronic infection, including HIV, HCV, HBV, tuberculosis; 8. Malignancy or history of malignancy; 8\. Other conditions that investigators consider inappropriate for this study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Active refractory rheumatoid arthritis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A new ankle? researchers track 400 people with an implant meant to restore movement
- Can a Job-Focused rehab program keep arthritis patients employed?
- Do rheumatic diseases quietly damage the Eye's oil glands?
- Hidden kidney damage may lurk in rheumatoid arthritis patients
- Can a new injection calm rheumatoid arthritis? an early trial puts ZB002 to the test
- Can a new knee implant design offer better Long-Term relief?