Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders

Rheumatoid Arthritis Clinical Trial

— EASi-RAIR  

Official title:

A Pilot Proof of Concept Study of the Effects of Administration of a Short Chain Fatty Acid (SCFA) Supplement in Rheumatoid Arthritis Inadequate Responders (EASi-RAIR)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718583
• Other study ID #: 22-01526
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: Rebecca B. Blank, MD, PhD
• Phone: 212-598-6149
• Email: Rebecca.blank[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health Orthopedic Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Arthritis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Microbiome Alpha Diversity	Measured by Shannon diversity index.	Baseline, Month 1 Post-Treatment Initiation
Secondary	Change in Serum SCFA Concentration	Measured via participant blood draws.	Baseline, Month 1 Post-Treatment Initiation
Secondary	Change in Fecal SCFA Concentration	Measured via participant stool samples.	Baseline, Month 1 Post-Treatment Initiation
Secondary	Change in Peripheral Regulatory T Cell Concentration	Measured via participant blood draws.	Up to Month 1 Post-Treatment Initiation