Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders

Not Applicable

Recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Dietary Supplement: Butyrate

• Registration Number: NCT05718583
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-01-30
• Study Start: 2023-02-01
• Study First Posted: 2023-02-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RA Patients who are Inadequate Responders to Current RA Treatment	Butyrate	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Microbiome Alpha Diversity	Baseline, Month 1 Post-Treatment Initiation	Measured by Shannon diversity index.

Secondary Outcome Measures

Name	Time	Method
Change in Serum SCFA Concentration	Baseline, Month 1 Post-Treatment Initiation	Measured via participant blood draws.
Change in Fecal SCFA Concentration	Baseline, Month 1 Post-Treatment Initiation	Measured via participant stool samples.
Change in Peripheral Regulatory T Cell Concentration	Up to Month 1 Post-Treatment Initiation	Measured via participant blood draws.

Trial Locations

Locations (1)

NYU Langone Health Orthopedic Center; 🇺🇸 New York, New York, United States