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Could a gut bacteria booster ease rheumatoid arthritis?

NCT ID NCT05718583

Disease control Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This pilot study tested whether a butyrate supplement, a type of short-chain fatty acid, could change the gut microbiome and immune responses in people with rheumatoid arthritis who didn't respond well to methotrexate. Twenty participants took the supplement for up to two months. Researchers collected stool, urine, and blood samples to measure changes in gut bacteria diversity and immune cells.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
butyrate (a short-chain fatty acid) dietary supplement
What this could lead to
If it works, this could point toward a simple dietary supplement to help control rheumatoid arthritis symptoms in people who don't respond well to standard treatments.
What could go wrong
This is a very small, early pilot study with only 20 participants and no placebo group. The main goal is to see if the supplement changes gut bacteria, not whether it improves arthritis symptoms. Results may not lead to a proven treatment.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Feb 2023

Finished

Feb 2025

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 years and older

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of RA meeting 2010 ACR/EULAR for RA and/or treating MD diagnosis 2. Inadequate response to MTX per treating MD at maximum tolerated dose. 3. Able and willing to provide written informed consent prior to any study specific procedures 4. Age 18 years and above at time of enrollment 5. Subjects not excluded based on race or ethnicity Exclusion Criteria: 1. Participants who are pregnant or are currently breastfeeding 2. History of sensitivity to study compound or any of their excipients 3. Previous intolerance to SCFA or related compounds 4. Current antibiotic treatment (within 3 months of screening) at discretion of PI 5. Current consumption of probiotics (within 3 months of screening) at discretion of PI 6. Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy) 7. Renal failure (eGFR \<30 or requiring dialysis) by history 8. History of other autoimmune disease at discretion of PI 9. Current immunodeficiency state (e.g., cancer, HIV, others)

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis

Contacts and locations

Locations

  • NYU Langone Health Orthopedic Center

    New York, New York, 10016, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.