Rheumatoid ArthritisPhase 2NCT05576597
Effect of Butyrate Supplement on Rheumatoid Arthritis
A Phase 2 study testing Sodium Butyrate in people with Rheumatoid Arthritis, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study is a pilot study to evaluate the safety and efficacy of administering butyrate supplement on rheumatoid arthritis patients. Thirty participants will be included to receive butyrate supplement for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Sodium Butyrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2022to 15 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years of age at the time of screening, weight≥35 kg.
- Diagnosed with rheumatoid arthritis satisfying the 1987 American College of Rheumatology classification criteria.
- Stable treatment, including DMARDs (disease-modifying anti-rheumatic drugs) and glucocorticoids, was stable in dose for at least 4 weeks, and no biological agents were used during the first 12 weeks of enrollment.
- Have given written informed consent
Who cannot join
- Patient presenting or having a history of other autoimmune diseases (such as Sjogren's syndrome, systemic lupus erythematosus, systemic sclerosis, vasculitis, etc.) and other arthritic diseases (such as spinal arthritis, psoriatic arthritis, reactive arthritis, etc.)
- Patient with ongoing or previous Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme
- Patient with significantly impaired bone marrow function or significant anemia, leucopenia or thrombocytopenia induced by other disease
- Patient with persistent or severe infection within 3 months before enrollment
- Patient with uncontrolled hypertension, uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, terminal illness or other medical condition which would put the patient at risk of participating in the study according to the opinion of investigator
- Patient with cardiovascular, hepatic, neurological, endocrine, or other major systemic disease, which may make implementation of the protocol or interpretation of the study results difficult
Show all 18Show fewer
- Patient who has severe hypoproteinemia (e.g., in case of severe liver disease or nephrotic syndrome), with serum albumin < 30 g/L)
- Patient who has moderate or severe impairment of renal function (the estimated glomerular filtration rate was < 60 mL/min/1.73 m2)
- Patient with impairment of liver function or persisting Alanine transaminase (ALT) or Aspartate aminotransferase (AST) elevations of more than 2-fold the upper limit of normal
- Patient with Known HIV positive status or positive serology for hepatitis B or C
- Pregnant or breastfeeding woman
- Women of childbearing potential
- Men wishing to father children during the course of the study or within the 24 months thereafter (or 3 months with the washout procedure)
- Patient with a congenital or acquired severe immuno-deficiency, a history of cancer or lymphoproliferative disease, or any patient who has received total lymphoid irradiation.
- Patient who enrolled in any other clinical trial involving off-label use of an investigational drug or device, or any other type of medical research
- Patient using any biologic agent such as anti-tumor necrosis factor, IL-6 receptor antagonist, anti-CD20 monoclonal antibody within 3 months prior to the first dose of treatment.
- Patient whose BMI (body mass index) is under 18.5 kg/m2 or more than 30 kg/m2
- Patient with history of drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Pilot Study to Evaluate Efficacy and Safety of Butyrate Supplement in the Treatment of Rheumatoid Arthritis
This study is a pilot study to evaluate the safety and efficacy of administering butyrate supplement on rheumatoid arthritis patients. Thirty participants will be included to receive butyrate supplement for 12 weeks. Changes of immune cell subtypes, markers of intestinal damage, intestinal flora and other laboratory indicators will be monitored.
Read the detailed description
This is a single center, uncontrolled, open-label study to assess the efficacy and safety of butyrate supplement plus standard therapy in rheumatoid arthritis(RA). The patients will be given 2 sodium butyrate capsules (containing 1200 mg of sodium butyrate) daily as supplemental therapy. The objective is to assess the effects of 12 weeks of sodium butyrate supplementation on intestinal inflammation and immune regulation in patients with RA, specifically changes in T-cell subtypes and biomarkers associated with intestinal injury. Clinical manifestations and other laboratory indices will also be monitored.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Sodium Butyrate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium ButyrateDrug
2 capsules butyrate supplement once a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Butyrate supplement | Experimental | 2 capsules butyrate supplement (containing 1200 mg of butyric acid ) once a day for 12 weeks Drug: sodium butyrate Receives: Drug: Sodium Butyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in disease Activity Score in 28 joints (DAS28)
Evaluating changes in DAS28 before and after treatment. DAS28 was calculated by the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (mm/h) or c-reactive protein (CRP) (mg/L), and patient's global assessment (PGA) of disease activity (based on the visual analog score [VAS], 0-100mm). Compared with the baseline, a lower DAS28 would mean an improvement in disease activity. Conversely, an increase in DAS28 indicates a deterioration in disease activity.
Measured: Baseline,12 weeks
Secondary outcomes (9)
Changes in the simplified disease activity index (SDAI)
Evaluating changes in SDAI before and after treatment. The SDAI is a composite score based on the tender joints of 28 joints (TJC28), tender joints of 28 joints (SJC28), patients' and physicians' global assessments of disease activity (based on the visual analog score [VAS], 0-10cm), and c-reactive protein (CRP). Compared with the baseline, a lower SDAI would mean an improvement in disease activity. Conversely, an increase in SDAI indicates a deterioration in disease activity.
Measured: Baseline and 12 weeks
Changes in the clinical disease activity index (CDAI)
Evaluating changes in CDAI before and after treatment. The Clinical Disease Activity Index (CDAI) is a composite score based on the TJC28, SJC28, and patients'and physicians'assessments (based on the visual analog score [VAS], 0-10cm). Compared with the baseline, a lower CDAI would mean an improvement in disease activity. Conversely, an increase in CDAI indicates a deterioration in disease activity.
Measured: Baseline and 12 weeks
Changes in T cell subtypes.
Evaluating changes in the percentage of T cell subtypes, especially T regulatory cells, in peripheral blood before and after treatment.
Measured: Baseline, 4 weeks and 12 weeks
Changes in c-reactive protein (CRP).
Evaluating changes in concentration of CRP (mg/L) before and after treatment.
Measured: Baseline, 4 weeks and 12 weeks
Changes in erythrocyte sedimentation rate (ESR).
Evaluating changes in concentration of ESR (mm/h) before and after treatment.
Measured: Baseline, 4 weeks and 12 weeks
Changes in serum lipopolysaccharide-binding protein (LBP)
Evaluating changes in LBP concentration in serum before and after treatment.
Measured: Baseline, 4 weeks and 12 weeks
Changes in serum intestinal fatty acid-binding protein (I-FABP)
Evaluating changes in I-FABP concentration in serum before and after treatment.
Measured: Baseline, 4 weeks and 12 weeks
Changes in serum soluble cluster of differentiation 14 (sCD14)
Evaluating changes in sCD14 concentration in serum before and after treatment.
Measured: Baseline, 4 weeks and 12 weeks
Numbers of participants with treatment-related adverse events
Adverse effects include fever, rash, abnormal liver and kidney function, new-onset infection, and any abnormal measures associated with experimental drugs.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start23 Aug 2022
- Primary completion1 Oct 2023
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhanguo Li, Peking University People's Hospital
- Investigators
- Zhanguo Li, Principal investigator, Peking University Institute of Rheuamotology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576597
- Sponsor's protocol ID
- ButyrateRA
- Status last verified
- Aug 2024
- First submitted
- 7 Oct 2022
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Efficacy and Safety of Butyrate Supplement in the Treatment of Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05576597
- Acronym / sponsor ID
- ButyrateRA
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a pilot study to evaluate the safety and efficacy of administering butyrate supplement on rheumatoid arthritis patients. Thirty participants will be included to receive butyrate supplement for 12 weeks. Changes of immune cell subtypes, markers of intestinal damage, intestinal flora and other laboratory indicators will be monitored.
Detailed description
This is a single center, uncontrolled, open-label study to assess the efficacy and safety of butyrate supplement plus standard therapy in rheumatoid arthritis(RA). The patients will be given 2 sodium butyrate capsules (containing 1200 mg of sodium butyrate) daily as supplemental therapy. The objective is to assess the effects of 12 weeks of sodium butyrate supplementation on intestinal inflammation and immune regulation in patients with RA, specifically changes in T-cell subtypes and biomarkers associated with intestinal injury. Clinical manifestations and other laboratory indices will also be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Butyrate supplement | Experimental | Drug: Sodium Butyrate2 capsules butyrate supplement (containing 1200 mg of butyric acid ) once a day for 12 weeks Drug: sodium butyrate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥18 years of age at the time of screening, weight≥35 kg.
- Diagnosed with rheumatoid arthritis satisfying the 1987 American College of Rheumatology classification criteria.
- Stable treatment, including DMARDs (disease-modifying anti-rheumatic drugs) and glucocorticoids, was stable in dose for at least 4 weeks, and no biological agents were used during the first 12 weeks of enrollment.
- Have given written informed consent
Key exclusion criteria (18 listed)
- Patient presenting or having a history of other autoimmune diseases (such as Sjogren's syndrome, systemic lupus erythematosus, systemic sclerosis, vasculitis, etc.) and other arthritic diseases (such as spinal arthritis, psoriatic arthritis, reactive arthritis, etc.)
- Patient with ongoing or previous Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme
- Patient with significantly impaired bone marrow function or significant anemia, leucopenia or thrombocytopenia induced by other disease
- Patient with persistent or severe infection within 3 months before enrollment
- Patient with uncontrolled hypertension, uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, terminal illness or other medical condition which would put the patient at risk of participating in the study according to the opinion of investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Butyrate2 capsules butyrate supplement once a day for 12 weeks | Drug | Butyrate supplement |
Primary outcome
Changes in disease Activity Score in 28 joints (DAS28)
Time frame: Baseline,12 weeks
Evaluating changes in DAS28 before and after treatment. DAS28 was calculated by the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (mm/h) or c-reactive protein (CRP) (mg/L), and patient's global assessment (PGA) of disease activity (based on the visual analog score [VAS], 0-100mm). Compared with the baseline, a lower DAS28 would mean an improvement in disease activity. Conversely, an increase in DAS28 indicates a deterioration in disease activity.
9 secondary outcomes
Changes in the simplified disease activity index (SDAI)
Time frame: Baseline and 12 weeks
Changes in the clinical disease activity index (CDAI)
Time frame: Baseline and 12 weeks
Changes in T cell subtypes.
Time frame: Baseline, 4 weeks and 12 weeks
Changes in c-reactive protein (CRP).
Time frame: Baseline, 4 weeks and 12 weeks
Changes in erythrocyte sedimentation rate (ESR).
Time frame: Baseline, 4 weeks and 12 weeks
Changes in serum lipopolysaccharide-binding protein (LBP)
Time frame: Baseline, 4 weeks and 12 weeks
Changes in serum intestinal fatty acid-binding protein (I-FABP)
Time frame: Baseline, 4 weeks and 12 weeks
Changes in serum soluble cluster of differentiation 14 (sCD14)
Time frame: Baseline, 4 weeks and 12 weeks
Numbers of participants with treatment-related adverse events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhanguo Li principal investigator
Peking University Institute of Rheuamotology and Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Butyrate in people with Rheumatoid Arthritis, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in disease Activity Score in 28 joints (DAS28) (time frame: Baseline,12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.