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| Name | Class |
|---|---|
| Arthritis Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RA Patients who are Inadequate Responders to Current RA Treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butyrate | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Microbiome Alpha Diversity | 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. | Baseline, Month 1 Post-Treatment Initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum SCFA Concentration | Measured via participant blood draws. | Baseline, Month 1 Post-Treatment Initiation |
| Change in Fecal SCFA Concentration | Measured via participant stool samples. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Scher, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health Orthopedic Center | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Rebecca.blank@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Rebecca.blank@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Microbiome Alpha Diversity | 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. | Methotrexate inadequate responders who were given a butyrate supplement along with methotrexate as SOC for one month. | Posted | Median | Inter-Quartile Range | index | Baseline, Month 1 Post-Treatment Initiation |
|
1 month
PI monitored for AEs at each follow up visit and by participant self-reporting between follow up visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca B. Blank, MD, PhD | NYU Langone Health | 646-501-7400 | Rebecca.Blank@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2025 | Apr 9, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 21, 2023 | Apr 9, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D002087 | Butyrates |
| D020148 | Butyric Acid |
| ID | Term |
|---|---|
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
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|
| Baseline, Month 1 Post-Treatment Initiation |
| Change in Peripheral Regulatory T Cell Concentration | Measured via participant blood draws. Percentage of peripheral regulatory T cells were determined by flow cytometry at baseline and 1 month after intervention. | Baseline, Month 1 Post-Treatment Initiation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Change in Serum SCFA Concentration | Measured via participant blood draws. | Posted | Number | micromolar (uM) | Baseline, Month 1 Post-Treatment Initiation |
|
|
|
| Secondary | Change in Fecal SCFA Concentration | Measured via participant stool samples. | Not Posted | Aug 2026 | Baseline, Month 1 Post-Treatment Initiation | Participants |
| Secondary | Change in Peripheral Regulatory T Cell Concentration | Measured via participant blood draws. Percentage of peripheral regulatory T cells were determined by flow cytometry at baseline and 1 month after intervention. | Methotrexate inadequate responders who were given a butyrate supplement along with methotrexate as SOC for one month. | Posted | Mean | Standard Deviation | Percentage of Regulatory T Cells | Baseline, Month 1 Post-Treatment Initiation |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |