Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders

NCT05718583 | Completed

• 1 other identifier: 22-01526
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Rheumatoid Arthritis; Short Chain Fatty Acid; Butyrate; Microbiome; Methotrexate

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Microbiome Alpha Diversity

  Measured by Shannon diversity index.

  Baseline, Month 1 Post-Treatment Initiation

Secondary Outcomes (3)

• Change in Serum SCFA Concentration

  Baseline, Month 1 Post-Treatment Initiation

• Change in Fecal SCFA Concentration

  Baseline, Month 1 Post-Treatment Initiation

• Change in Peripheral Regulatory T Cell Concentration

  Up to Month 1 Post-Treatment Initiation

Study Arms (1)

RA Patients who are Inadequate Responders to Current RA Treatment

EXPERIMENTAL

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.

Dietary Supplement: Butyrate

Interventions

Butyrate 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.

Also known as: Butyrate; butyric acid

RA Patients who are Inadequate Responders to Current RA Treatment

Eligibility Criteria

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

You may qualify if:

• Diagnosis of RA meeting 2010 ACR/EULAR for RA and/or treating MD diagnosis
• Inadequate response to MTX per treating MD at maximum tolerated dose.
• Able and willing to provide written informed consent prior to any study specific procedures
• Age 18 years and above at time of enrollment
• Subjects not excluded based on race or ethnicity

You may not qualify if:

• Participants who are pregnant or are currently breastfeeding
• History of sensitivity to study compound or any of their excipients
• Previous intolerance to SCFA or related compounds
• Current antibiotic treatment (within 3 months of screening) at discretion of PI
• Current consumption of probiotics (within 3 months of screening) at discretion of PI
• Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)
• Renal failure (eGFR \<30 or requiring dialysis) by history
• History of other autoimmune disease at discretion of PI
• Current immunodeficiency state (e.g., cancer, HIV, others)

Sponsors & Collaborators

• NYU Langone Health: lead
• Arthritis Foundation: collaborator

Study Sites (1)

NYU Langone Health Orthopedic Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Butyrates; Butyric Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Jose Scher, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: February 1, 2023
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Rebecca.blank@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)