Effect of Butyrate Supplement on Rheumatoid Arthritis

NCT05576597 | Completed Phase 2 DMC

• 1 other identifier: ButyrateRA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. Changes of immune cell subtypes, markers of intestinal damage, intestinal flora and other laboratory indicators will be monitored.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline,12 weeks

Secondary Outcomes (9)

• Changes in the simplified disease activity index (SDAI)

  Baseline and 12 weeks

• Changes in the clinical disease activity index (CDAI)

  Baseline and 12 weeks

• Changes in T cell subtypes.

  Baseline, 4 weeks and 12 weeks

• Changes in c-reactive protein (CRP).

  Baseline, 4 weeks and 12 weeks

• Changes in erythrocyte sedimentation rate (ESR).

  Baseline, 4 weeks and 12 weeks

Study Arms (1)

Butyrate supplement

EXPERIMENTAL

2 capsules butyrate supplement (containing 1200 mg of butyric acid ) once a day for 12 weeks Drug: sodium butyrate

Drug: Sodium Butyrate

Interventions

Sodium Butyrate DRUG

2 capsules butyrate supplement once a day for 12 weeks

Butyrate supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Department of Rheumatology and Immunology, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Butyric Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Zhanguo Li

  Peking University Institute of Rheuamotology and Immunology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: August 23, 2022
• Primary Completion: October 1, 2023
• Study Completion: June 15, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

CN (1)