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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: Completed NA study of Rheumatoid Arthritis, sponsored by NYU Langone Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in alpha diversity by Shannon Entropy of the gut microbiota after taking butyrate supplement for one month was measured. Alpha diversity by Shannon Entropy quantifies the complexity of a single community by accounting for both species richness (total number of types) and species evenness (distribution of abundance). It calculates the uncertainty of predicting the identity of an individual picked at random, where higher entropy implies higher diversity.
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 |
What the finished NCT05718583 record still lists
NCT05718583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 4,691-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05718583's enrollment target sits among peer trials
20 177th of 197 higher than 18 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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