A Pilot Proof of Concept Study of the Effects of Administration of SCFA in Rheumatoid Arthritis (EASi-RA)

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05152615
• Other study ID #: 20-02068
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 17, 2021
• Est. completion date: March 2024

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: n/a
• 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 along with methotrexate as first line treatment of new onset rheumatoid arthritis (NORA) patients. Up to 50 participants will be included to obtain a sample size of at least 16 participants taking the oral supplement. The study team hypothesizes 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, 2 and 4 months with an optional 6-month time point. Fecal microbiome will be analyzed. Adaptive immune responses will be analyzed from participant blood samples.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. New diagnosis of rheumatoid arthritis (RA) (<6 months) meeting 2010 ACR/EULAR for RA

2. Scheduled to begin treatment with methotrexate at any dose as standard medical care

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 (within 3 months of screening) treatment with csDMARDs

5. Current or past (ever) treatment with biologic therapies (including but not limited to anti-TNF, anti-IL-17, anti-IL-12/23)

6. Current antibiotic treatment (within 3 months of screening)

7. Current consumption of probiotics (within 3 months of screening)

8. Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)

9. Renal failure (eGFR <30 or requiring dialysis) by history

10. History of other autoimmune disease

11. Current immunodeficiency state (e.g., cancer, HIV, others)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Dietary Supplement:
• Short Chain Fatty Acids (SCFA) Dietary Supplement
Butryate 1000 mg three times daily will be used in this study.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Percentage of Circulating T Regulatory Cells (Treg)		Baseline, Visit 2 (60 days)
Secondary	Change in gut microbiota composition after SCFA supplementation		Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)
Secondary	Change in Fecal SCFA Concentration after SCFA supplementation		Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)
Secondary	Change in Interleukin-10 (IL-10) Production Levels after SCFA Supplementation		Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)