Back to resultsA Pilot Proof of Concept Study of the Effects of Administration of SCFA in Rheumatoid Arthritis (EASi-RA)
Primary Purpose
Rheumatoid Arthritis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Short Chain Fatty Acids (SCFA) Dietary Supplement
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Short Chain Fatty Acid (SCFA), Butyrate, Gut Microbiome
Eligibility Criteria
Inclusion Criteria:
- New diagnosis of rheumatoid arthritis (RA) (<6 months) meeting 2010 ACR/EULAR for RA
- Scheduled to begin treatment with methotrexate at any dose as standard medical care
- Able and willing to provide written informed consent prior to any study specific procedures
- Age 18 years and above at time of enrollment
- Subjects not excluded based on race or ethnicity
Exclusion Criteria:
- Participants who are pregnant or are currently breastfeeding
- History of sensitivity to study compound or any of their excipients
- Previous intolerance to SCFA or related compounds
- Current (within 3 months of screening) treatment with csDMARDs
- Current or past (ever) treatment with biologic therapies (including but not limited to anti-TNF, anti-IL-17, anti-IL-12/23)
- Current antibiotic treatment (within 3 months of screening)
- Current consumption of probiotics (within 3 months of screening)
- Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)
- Renal failure (eGFR <30 or requiring dialysis) by history
- History of other autoimmune disease
- Current immunodeficiency state (e.g., cancer, HIV, others)
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
New Onset Rheumatoid Arthritis (NORA) Patient
Arm Description
NORA patients receiving methotraxate as first line therapy (standard of care) will take additional oral SCFA supplementation for the purposes of the study.
Outcomes
Primary Outcome Measures
Change in Percentage of Circulating T Regulatory Cells (Treg)
Secondary Outcome Measures
Change in gut microbiota composition after SCFA supplementation
Change in Fecal SCFA Concentration after SCFA supplementation
Change in Interleukin-10 (IL-10) Production Levels after SCFA Supplementation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05152615
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Short Chain Fatty Acid (SCFA), Butyrate, Gut Microbiome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
New Onset Rheumatoid Arthritis (NORA) Patient
Arm Type
Experimental
Arm Description
NORA patients receiving methotraxate as first line therapy (standard of care) will take additional oral SCFA supplementation for the purposes of the study.
Intervention Type
Dietary Supplement
Intervention Name(s)
Short Chain Fatty Acids (SCFA) Dietary Supplement
Other Intervention Name(s)
Butyrate
Intervention Description
Butryate 1000 mg three times daily will be used in this study.
Primary Outcome Measure Information:
Title
Change in Percentage of Circulating T Regulatory Cells (Treg)
Time Frame
Baseline, Visit 2 (60 days)
Secondary Outcome Measure Information:
Title
Change in gut microbiota composition after SCFA supplementation
Time Frame
Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)
Title
Change in Fecal SCFA Concentration after SCFA supplementation
Time Frame
Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)
Title
Change in Interleukin-10 (IL-10) Production Levels after SCFA Supplementation
Time Frame
Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
New diagnosis of rheumatoid arthritis (RA) (<6 months) meeting 2010 ACR/EULAR for RA
Scheduled to begin treatment with methotrexate at any dose as standard medical care
Able and willing to provide written informed consent prior to any study specific procedures
Age 18 years and above at time of enrollment
Subjects not excluded based on race or ethnicity
Exclusion Criteria:
Participants who are pregnant or are currently breastfeeding
History of sensitivity to study compound or any of their excipients
Previous intolerance to SCFA or related compounds
Current (within 3 months of screening) treatment with csDMARDs
Current or past (ever) treatment with biologic therapies (including but not limited to anti-TNF, anti-IL-17, anti-IL-12/23)
Current antibiotic treatment (within 3 months of screening)
Current consumption of probiotics (within 3 months of screening)
Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)
Renal failure (eGFR <30 or requiring dialysis) by history
History of other autoimmune disease
Current immunodeficiency state (e.g., cancer, HIV, others)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca B Blank, MD, PhD
Phone
212-501-7642
Email
Rebecca.Blank@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Scher, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rebecca B Blank, MD, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca B Blank, MD, PhD
Email
Rebecca.Blank@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Jose Scher, MD
First Name & Middle Initial & Last Name & Degree
Rebecca B Blank, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available upon reasonable request.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Rebecca.Blank@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
A Pilot Proof of Concept Study of the Effects of Administration of SCFA in Rheumatoid Arthritis (EASi-RA)
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