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NCT05718583 · ClinicalTrials.gov registry record · NA
Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders
A NA study of Rheumatoid Arthritis, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05718583 is a NA study of Rheumatoid Arthritis that has completed, run by NYU Langone Health. The registered enrollment target is 20 participants, below the 4,691-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05718583, a NA study of Rheumatoid Arthritis, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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 to Rheumatoid Arthritis (RA) patients with inadequate response to methotrexate (MTX). The study will include up to 35 participants to obtain a sample size of at least 25 participants taking the oral supplement. The researchers hypothesize 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, 1 month, and with an optional 2 month time-point. Fecal microbiome will be analyzed. Adaptive immune responses will be analyzed from participant blood samples.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Butyrate
Study Locations (1)
New York
- NYU Langone Health Orthopedic Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2025-02-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05718583
The ClinicalTrials.gov registry entry for NCT05718583 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,691-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (100% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention - of which Butyrate is the first listed.
NCT05718583 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05718583 about?
NCT05718583 is a clinical study titled "Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders". This study is a pilot, proof of concept study to determine the effects of administering an oral short-chain fatty acid (SCFA) supplement to Rheumatoid Arthritis (RA) patients with inadequate response to methotrexate (MTX). The study will include up to 35 participants to obtain a sample size of at le...
What is the current status of trial NCT05718583?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2023-02-01. Estimated completion is 2025-02-20.
What conditions does trial NCT05718583 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT05718583?
The interventions under investigation include: Butyrate (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05718583?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05718583 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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