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NCT05152615 · ClinicalTrials.gov registry record · NA
A Pilot Proof of Concept Study of the Effects of Administration of SCFA in Rheumatoid Arthritis (EASi-RA)
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT05152615 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 24 participants.
The verdict
NCT05152615, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study 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.
Interventions
- DIETARY_SUPPLEMENT Short Chain Fatty Acids (SCFA) Dietary Supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-11-17 |
| Est. Completion | 2024-03-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05152615
The ClinicalTrials.gov registry entry for NCT05152615 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Short Chain Fatty Acids (SCFA) Dietary Supplement is the first listed.
NCT05152615 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05152615 about?
NCT05152615 is a clinical study titled "A Pilot Proof of Concept Study of the Effects of Administration of 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 o...
What is the current status of trial NCT05152615?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2021-11-17. Estimated completion is 2024-03-15.
What interventions are being tested in trial NCT05152615?
The interventions under investigation include: Short Chain Fatty Acids (SCFA) Dietary Supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05152615?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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