NCT05152615Completed
A Pilot Proof of Concept Study of the Effects of Administration of SCFA in Rheumatoid Arthritis (EASi-RA)
A Pilot Proof of Concept Study of the Effects of Administration of a Short Chain Fatty Acid (SCFA) in Rheumatoid Arthritis (EASi-RA)
Source: ClinicalTrials.gov · Last updated 24 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 1 Dec 2021
- Start date
- 17 Nov 2021
- Primary completion date
- 15 Mar 2024
- Lead sponsor
- NYU Langone Health
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05152615
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 17 Nov 2021 to the primary completion date, 15 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- History of sensitivity to study compound or any of their excipients
- Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)
- History of other autoimmune disease
- Current immunodeficiency state (e.g., cancer, HIV, others)
Lab values
- Renal failure (eGFR \<30 or requiring dialysis) by history
Other
- Participants who are pregnant or are currently breastfeeding
- Current antibiotic treatment (within 3 months of screening)
- Current consumption of probiotics (within 3 months of screening)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.