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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
2 capsules butyrate supplement once a day for 12 weeks
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, China
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.
Time frame: Baseline,12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 4 weeks and 12 weeks
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Changes in c-reactive protein (CRP).
Evaluating changes in concentration of CRP (mg/L) before and after treatment.
Time frame: Baseline, 4 weeks and 12 weeks
Changes in erythrocyte sedimentation rate (ESR).
Evaluating changes in concentration of ESR (mm/h) before and after treatment.
Time frame: Baseline, 4 weeks and 12 weeks
Changes in serum lipopolysaccharide-binding protein (LBP)
Evaluating changes in LBP concentration in serum before and after treatment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks