Rheumatoid ArthritisNCT05152615
A Pilot Proof of Concept Study of the Effects of Administration of SCFA in Rheumatoid Arthritis (EASi-RA)
A study testing Short Chain Fatty Acids (SCFA) Dietary Supplement in people with Rheumatoid Arthritis, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Short Chain Fatty Acids (SCFA) Dietary Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2021to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Short Chain Fatty Acids (SCFA) Dietary Supplement
- Keywords
- Short Chain Fatty Acid (SCFA), Butyrate, Gut Microbiome
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Chain Fatty Acids (SCFA) Dietary SupplementDietary supplement
Also called Butyrate
Butryate 1000 mg three times daily will be used in this study.
| Study group | Role | What they receive |
|---|---|---|
| New Onset Rheumatoid Arthritis (NORA) Patient | Experimental | NORA patients receiving methotraxate as first line therapy (standard of care) will take additional oral SCFA supplementation for the purposes of the study. Receives: Dietary Supplement: Short Chain Fatty Acids (SCFA) Dietary Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage of Circulating T Regulatory Cells (Treg)
Measured: Baseline, Visit 2 (60 days)
Secondary outcomes (3)
Change in gut microbiota composition after SCFA supplementation
Measured: Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)
Change in Fecal SCFA Concentration after SCFA supplementation
Measured: Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)
Change in Interleukin-10 (IL-10) Production Levels after SCFA Supplementation
Measured: Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start17 Nov 2021
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Scher, MD, Principal investigator, NYU Langone HealthRebecca B Blank, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152615
- Sponsor's protocol ID
- 20-02068
- Status last verified
- Jun 2024
- First submitted
- 1 Dec 2021
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05152615
- Acronym / sponsor ID
- 20-02068
- Conditions
- Rheumatoid Arthritis
- Keywords
- Short Chain Fatty Acid (SCFA), Butyrate, Gut Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New Onset Rheumatoid Arthritis (NORA) Patient | Experimental | Dietary Supplement: Short Chain Fatty Acids (SCFA) Dietary SupplementNORA patients receiving methotraxate as first line therapy (standard of care) will take additional oral SCFA supplementation for the purposes of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Chain Fatty Acids (SCFA) Dietary SupplementAlso: ButyrateButryate 1000 mg three times daily will be used in this study. | Dietary supplement | New Onset Rheumatoid Arthritis (NORA) Patient |
Primary outcome
Change in Percentage of Circulating T Regulatory Cells (Treg)
Time frame: Baseline, Visit 2 (60 days)
3 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Scher, MD principal investigator
NYU Langone Health
Rebecca B Blank, MD, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Chain Fatty Acids (SCFA) Dietary Supplement in people with Rheumatoid Arthritis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percentage of Circulating T Regulatory Cells (Treg) (time frame: Baseline, Visit 2 (60 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.