Effect of Butyrate Supplement on Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT05576597
- Lead Sponsor
- Peking University People's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria:<br><br> - Male or female =18 years of age at the time of screening, weight=35 kg.<br><br> - Diagnosed with rheumatoid arthritis satisfying the 1987 American College of<br> Rheumatology classification criteria.<br><br> - Stable treatment, including DMARDs (disease-modifying anti-rheumatic drugs) and<br> glucocorticoids, was stable in dose for at least 4 weeks, and no biological agents<br> were used during the first 12 weeks of enrollment.<br><br> - Have given written informed consent<br><br>Exclusion Criteria:<br><br> - Patient presenting or having a history of other autoimmune diseases (such as<br> Sjogren's syndrome, systemic lupus erythematosus, systemic sclerosis, vasculitis,<br> etc.) and other arthritic diseases (such as spinal arthritis, psoriatic arthritis,<br> reactive arthritis, etc.)<br><br> - Patient with ongoing or previous Stevens-Johnson syndrome, toxic epidermal<br> necrolysis or erythema multiforme<br><br> - Patient with significantly impaired bone marrow function or significant anemia,<br> leucopenia or thrombocytopenia induced by other disease<br><br> - Patient with persistent or severe infection within 3 months before enrollment<br><br> - Patient with uncontrolled hypertension, uncontrolled diabetes, unstable ischemic<br> heart disease, active inflammatory bowel disease, active peptic ulcer disease,<br> terminal illness or other medical condition which would put the patient at risk of<br> participating in the study according to the opinion of investigator<br><br> - Patient with cardiovascular, hepatic, neurological, endocrine, or other major<br> systemic disease, which may make implementation of the protocol or interpretation of<br> the study results difficult<br><br> - Patient who has severe hypoproteinemia (e.g., in case of severe liver disease or<br> nephrotic syndrome), with serum albumin < 30 g/L)<br><br> - Patient who has moderate or severe impairment of renal function (the estimated<br> glomerular filtration rate was < 60 mL/min/1.73 m2)<br><br> - Patient with impairment of liver function or persisting Alanine transaminase (ALT)<br> or Aspartate aminotransferase (AST) elevations of more than 2-fold the upper limit<br> of normal<br><br> - Patient with Known HIV positive status or positive serology for hepatitis B or C<br><br> - Pregnant or breastfeeding woman<br><br> - Women of childbearing potential<br><br> - Men wishing to father children during the course of the study or within the 24<br> months thereafter (or 3 months with the washout procedure)<br><br> - Patient with a congenital or acquired severe immuno-deficiency, a history of cancer<br> or lymphoproliferative disease, or any patient who has received total lymphoid<br> irradiation.<br><br> - Patient who enrolled in any other clinical trial involving off-label use of an<br> investigational drug or device, or any other type of medical research<br><br> - Patient using any biologic agent such as anti-tumor necrosis factor, IL-6 receptor<br> antagonist, anti-CD20 monoclonal antibody within 3 months prior to the first dose of<br> treatment.<br><br> - Patient whose BMI (body mass index) is under 18.5 kg/m2 or more than 30 kg/m2<br><br> - Patient with history of drug or alcohol abuse
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in disease Activity Score in 28 joints (DAS28)
- Secondary Outcome Measures
Name Time Method Changes in the simplified disease activity index (SDAI);Changes in the clinical disease activity index (CDAI);Changes in T cell subtypes.;Changes in c-reactive protein (CRP).;Changes in erythrocyte sedimentation rate (ESR).;Changes in serum lipopolysaccharide-binding protein (LBP);Changes in serum intestinal fatty acid-binding protein (I-FABP);Changes in serum soluble cluster of differentiation 14 (sCD14);Numbers of participants with treatment-related adverse events