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

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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

Tracking Information
First Submitted Date  ICMJE December 1, 2021
First Posted Date  ICMJE December 10, 2021
Last Update Posted Date October 27, 2022
Actual Study Start Date  ICMJE November 17, 2021
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2021)		 Change in Percentage of Circulating T Regulatory Cells (Treg) [ Time Frame: Baseline, Visit 2 (60 days) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2021)
  • Change in gut microbiota composition after SCFA supplementation [ Time Frame: Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days) ]
  • Change in Fecal SCFA Concentration after SCFA supplementation [ Time Frame: Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Proof of Concept Study of the Effects of Administration of SCFA in Rheumatoid Arthritis (EASi-RA)
Official Title  ICMJE A Pilot Proof of Concept Study of the Effects of Administration of a Short Chain Fatty Acid (SCFA) in Rheumatoid Arthritis (EASi-RA)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Dietary Supplement: Short Chain Fatty Acids (SCFA) Dietary Supplement
Butryate 1000 mg three times daily will be used in this study.
Other Name: Butyrate
Study Arms  ICMJE 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.
Intervention: Dietary Supplement: Short Chain Fatty Acids (SCFA) Dietary Supplement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 8, 2021)		 50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2024
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rebecca B Blank, MD, PhD 212-501-7642 Rebecca.Blank@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05152615
Other Study ID Numbers  ICMJE 20-02068
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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.
Current Responsible Party NYU Langone Health
Original Responsible Party Same as current
Current Study Sponsor  ICMJE NYU Langone Health
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jose Scher, MD NYU Langone Health
Principal Investigator: Rebecca B Blank, MD, PhD NYU Langone Health
PRS Account NYU Langone Health
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP