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Dietary Supplement
SCFA Supplement for Rheumatoid Arthritis
N/A
Waitlist Available
Led By Rebecca B Blank, MD, PhD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years and above at time of enrollment
Scheduled to begin treatment with methotrexate at any dose as standard medical care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, visit 2 (60 days), visit 3 (120 days), visit 4 (180 days)
Awards & highlights
Study Summary
This trial is testing whether an oral supplement of short-chain fatty acids, given along with the drug methotrexate, can improve symptoms in people with new-onset rheumatoid arthritis.
Who is the study for?
This trial is for adults over 18 with a new diagnosis of rheumatoid arthritis, who are starting methotrexate treatment. It's not for pregnant or breastfeeding individuals, those with sensitivity to SCFA or its components, previous intolerance to SCFA, recent users of certain arthritis drugs, antibiotics or probiotics, and people with severe liver problems or renal failure.Check my eligibility
What is being tested?
The study tests if an oral supplement of Short Chain Fatty Acids (SCFA) can alter the gut microbiome and immune responses in patients newly diagnosed with rheumatoid arthritis when taken alongside methotrexate. Up to 50 participants will be enrolled to ensure at least 16 complete the study.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include digestive discomfort due to changes in gut bacteria from SCFA supplements and common side effects associated with methotrexate such as nausea and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am starting methotrexate treatment soon.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, visit 2 (60 days), visit 3 (120 days), visit 4 (180 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, visit 2 (60 days), visit 3 (120 days), visit 4 (180 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Percentage of Circulating T Regulatory Cells (Treg)
Secondary outcome measures
Change in Fecal SCFA Concentration after SCFA supplementation
Change in Interleukin-10 (IL-10) Production Levels after SCFA Supplementation
Change in gut microbiota composition after SCFA supplementation
Trial Design
1Treatment groups
Experimental Treatment
Group I: New Onset Rheumatoid Arthritis (NORA) PatientExperimental Treatment1 Intervention
NORA patients receiving methotraxate as first line therapy (standard of care) will take additional oral SCFA supplementation for the purposes of the study.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,697 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
407 Patients Enrolled for Rheumatoid Arthritis
Rebecca B Blank, MD, PhDPrincipal InvestigatorNYU Langone Health
Jose Scher, MDPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
1,372 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe liver problems, like fluid in the abdomen or bleeding issues.I have a condition that weakens my immune system.I am 18 years old or older.I have severe kidney problems or am on dialysis.I was recently diagnosed with rheumatoid arthritis.I am currently taking conventional synthetic disease-modifying antirheumatic drugs.I have been treated with biologic therapies before.I have taken antibiotics in the last 3 months.I am starting methotrexate treatment soon.
Research Study Groups:
This trial has the following groups:- Group 1: New Onset Rheumatoid Arthritis (NORA) Patient
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any enrollment opportunities in this research project presently?
"Affirmative, the data found on clinicaltrials.gov implies that this research is actively seeking participants. This trial was initially posted November 17th 2021 and had its most recent update October 25th 2022. Currently, they are recruiting 50 individuals at a single site."
Answered by AI
What is the magnitude of enrollees in this clinical investigation?
"Yes, according to information accessible on clinicaltrials.gov the study is actively enrolling patients. Initially posted on November 17th 2021 and last updated October 25th 2022, this trial intends to include 50 individuals from a single medical centre."
Answered by AI
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