Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Short Chain Fatty Acid, Butyrate, Microbiome, Methotrexate
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.
Interventions
DIETARY_SUPPLEMENTButyrate
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.
Sponsors
NYU Langone Health
Arthritis Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Microbiome Alpha Diversity | Baseline, Month 1 Post-Treatment Initiation | Change in alpha diversity by Shannon Entropy of the gut microbiota after taking butyrate supplement for one month was measured. Alpha diversity by Shannon Entropy quantifies the complexity of a single community by accounting for both species richness (total number of types) and species evenness (distribution of abundance). It calculates the uncertainty of predicting the identity of an individual picked at random, where higher entropy implies higher diversity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Month 1 Post-Treatment Initiation | Measured via participant blood draws. Percentage of peripheral regulatory T cells were determined by flow cytometry at baseline and 1 month after intervention. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJose Scher, MD
NYU Langone Health
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.63 years STANDARD_DEVIATION 16.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
None listed