Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders

NCT ID: NCT05718583

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-02-20

Brief Summary

This study is a pilot, proof of concept study to determine the effects of administering an oral short-chain fatty acid (SCFA) supplement to Rheumatoid Arthritis (RA) patients with inadequate response to methotrexate (MTX). The study will include up to 35 participants to obtain a sample size of at least 25 participants taking the oral supplement. The researchers hypothesize that oral SCFA will change the participants' gut microbiome and regulatory immune responses. Clinical data to assess for adverse events, stool, urine samples and peripheral blood will be collected at baseline, 1 month, and with an optional 2 month time-point. Fecal microbiome will be analyzed. Adaptive immune responses will be analyzed from participant blood samples.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RA Patients who are Inadequate Responders to Current RA Treatment

Oral butyrate will be taken at 1000 mg three times daily with meals by RA patients who have active disease and are currently taking methotrexate (MTX) at prescriber's recommended dose. There will be no dose escalation of the study supplement. Clinical data to assess for adverse events, stool, urine samples and peripheral blood will be collected at baseline, 1 month, and with an optional 2-month time-point.

Group Type: EXPERIMENTAL

Butyrate

Intervention Type: DIETARY_SUPPLEMENT

Participants will self-administer the oral Short Chain Fatty Acid (SCFA) Butyrate supplement three times daily with meals for up to 2 months. The minimum duration necessary for an "evaluable" participant will be 2 weeks of SCFA supplementation.

Interventions

Butyrate

Participants will self-administer the oral Short Chain Fatty Acid (SCFA) Butyrate supplement three times daily with meals for up to 2 months. The minimum duration necessary for an "evaluable" participant will be 2 weeks of SCFA supplementation.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Butyrate; butyric acid

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthritis Foundation

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Blank, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health Orthopedic Center

New York, New York, United States

Countries

United States

Other Identifiers

22-01526

Identifier Type: -

Identifier Source: org_study_id