Trial Outcomes & Findings for Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders (NCT NCT05718583)
NCT ID: NCT05718583
Last Updated: 2026-06-02
Results Overview
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.
COMPLETED
NA
20 participants
Baseline, Month 1 Post-Treatment Initiation
2026-06-02
Participant Flow
Participant milestones
| Measure |
RA Patients Who Are Inadequate Responders to Current RA Treatment
Oral butyrate will be taken at 1000 mg three times daily with meals by RA patients who have active disease and are currently taking methotrexate (MTX) at prescriber's recommended dose. There will be no dose escalation of the study supplement. 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.
Butyrate: Participants will self-administer the oral Short Chain Fatty Acid (SCFA) Butyrate supplement three times daily with meals for up to 2 months. The minimum duration necessary for an "evaluable" participant will be 2 weeks of SCFA supplementation.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
RA Patients Who Are Inadequate Responders to Current RA Treatment
Oral butyrate will be taken at 1000 mg three times daily with meals by RA patients who have active disease and are currently taking methotrexate (MTX) at prescriber's recommended dose. There will be no dose escalation of the study supplement. 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.
Butyrate: Participants will self-administer the oral Short Chain Fatty Acid (SCFA) Butyrate supplement three times daily with meals for up to 2 months. The minimum duration necessary for an "evaluable" participant will be 2 weeks of SCFA supplementation.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders
Baseline characteristics by cohort
| Measure |
RA Patients Who Are Inadequate Responders to Current RA Treatment
n=19 Participants
Oral butyrate will be taken at 1000 mg three times daily with meals by RA patients who have active disease and are currently taking methotrexate (MTX) at prescriber's recommended dose. There will be no dose escalation of the study supplement. 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.
Butyrate: Participants will self-administer the oral Short Chain Fatty Acid (SCFA) Butyrate supplement three times daily with meals for up to 2 months. The minimum duration necessary for an "evaluable" participant will be 2 weeks of SCFA supplementation.
|
|---|---|
|
Age, Continuous
|
45.63 years
STANDARD_DEVIATION 16.09 • n=9 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 1 Post-Treatment InitiationPopulation: Methotrexate inadequate responders who were given a butyrate supplement along with methotrexate as SOC for one month.
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.
Outcome measures
| Measure |
RA Patients Who Are Inadequate Responders to Current RA Treatment
n=7 Participants
Oral butyrate will be taken at 1000 mg three times daily with meals by RA patients who have active disease and are currently taking methotrexate (MTX) at prescriber's recommended dose. There will be no dose escalation of the study supplement. 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.
Butyrate: Participants will self-administer the oral Short Chain Fatty Acid (SCFA) Butyrate supplement three times daily with meals for up to 2 months. The minimum duration necessary for an "evaluable" participant will be 2 weeks of SCFA supplementation.
|
|---|---|
|
Change From Baseline in Microbiome Alpha Diversity
|
0.19 index
Interval -0.03 to 0.41
|
SECONDARY outcome
Timeframe: Baseline, Month 1 Post-Treatment InitiationMeasured via participant blood draws.
Outcome measures
| Measure |
RA Patients Who Are Inadequate Responders to Current RA Treatment
n=19 Participants
Oral butyrate will be taken at 1000 mg three times daily with meals by RA patients who have active disease and are currently taking methotrexate (MTX) at prescriber's recommended dose. There will be no dose escalation of the study supplement. 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.
Butyrate: Participants will self-administer the oral Short Chain Fatty Acid (SCFA) Butyrate supplement three times daily with meals for up to 2 months. The minimum duration necessary for an "evaluable" participant will be 2 weeks of SCFA supplementation.
|
|---|---|
|
Change in Serum SCFA Concentration
|
NA micromolar (uM)
Preliminary analyses of serum SCFA concentration were below the limit of detection therefore the investigators did not proceed with collecting data for this secondary outcome measure.
|
SECONDARY outcome
Timeframe: Baseline, Month 1 Post-Treatment InitiationMeasured via participant stool samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 1 Post-Treatment InitiationPopulation: Methotrexate inadequate responders who were given a butyrate supplement along with methotrexate as SOC for one month.
Measured via participant blood draws. Percentage of peripheral regulatory T cells were determined by flow cytometry at baseline and 1 month after intervention.
Outcome measures
| Measure |
RA Patients Who Are Inadequate Responders to Current RA Treatment
n=11 Participants
Oral butyrate will be taken at 1000 mg three times daily with meals by RA patients who have active disease and are currently taking methotrexate (MTX) at prescriber's recommended dose. There will be no dose escalation of the study supplement. 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.
Butyrate: Participants will self-administer the oral Short Chain Fatty Acid (SCFA) Butyrate supplement three times daily with meals for up to 2 months. The minimum duration necessary for an "evaluable" participant will be 2 weeks of SCFA supplementation.
|
|---|---|
|
Change in Peripheral Regulatory T Cell Concentration
|
0.646 Percentage of Regulatory T Cells
Standard Deviation 1.534
|
Adverse Events
RA Patients Who Are Inadequate Responders to Current RA Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place