Clinical trial NCT05152615: A Pilot Proof of Concept Study of the Effects of Administration of SCFA in Rheumatoid Arthritis (EASi-RA)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Short Chain Fatty Acid (SCFA)
Butyrate
Gut Microbiome
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Percentage of Circulating T Regulatory Cells (Treg)
timeFrame: Baseline, Visit 2 (60 days)
Secondary outcomes:
measure: Change in gut microbiota composition after SCFA supplementation
timeFrame: Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)
measure: Change in Fecal SCFA Concentration after SCFA supplementation
timeFrame: Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)
measure: Change in Interleukin-10 (IL-10) Production Levels after SCFA Supplementation
timeFrame: Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jose Scher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Rebecca B Blank, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: