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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05152615
Recruitment Status : Recruiting
First Posted : December 10, 2021
Last Update Posted : October 27, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Dietary Supplement: Short Chain Fatty Acids (SCFA) Dietary Supplement Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 17, 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: New Onset Rheumatoid Arthritis (NORA) Patient
NORA patients receiving methotraxate as first line therapy (standard of care) will take additional oral SCFA supplementation for the purposes of the study.
 Dietary Supplement: Short Chain Fatty Acids (SCFA) Dietary Supplement
Butryate 1000 mg three times daily will be used in this study.
Other Name: Butyrate


Outcome Measures
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Primary Outcome Measures :
  1. Change in Percentage of Circulating T Regulatory Cells (Treg) [ Time Frame: Baseline, Visit 2 (60 days) ]

Secondary Outcome Measures :
  1. Change in gut microbiota composition after SCFA supplementation [ Time Frame: Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days) ]
  2. Change in Fecal SCFA Concentration after SCFA supplementation [ Time Frame: Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days) ]
  3. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05152615


Contacts
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Contact: Rebecca B Blank, MD, PhD 212-501-7642 Rebecca.Blank@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Rebecca B Blank, MD, PhD       Rebecca.Blank@nyulangone.org   
Principal Investigator: Jose Scher, MD         
Principal Investigator: Rebecca B Blank, MD, PhD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Jose Scher, MD NYU Langone Health
Principal Investigator: Rebecca B Blank, MD, PhD NYU Langone Health
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT05152615    
Other Study ID Numbers: 20-02068
First Posted: December 10, 2021    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Short Chain Fatty Acid (SCFA)
Butyrate
Gut Microbiome
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases