Effect of Butyrate Supplement on Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Pilot Study to Evaluate Efficacy and Safety of Butyrate Supplement in the Treatment of Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05576597
• Other study ID #: ButyrateRA
• Status: Recruiting
• Phase: Phase 2
• Start date: August 23, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2022
• Source: Peking University People's Hospital
• Contact: Naidi Wang
• Phone: +8618811618179
• Email: pkuwnd[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a pilot study to evaluate the safety and efficacy of administering butyrate supplement on rheumatoid arthritis patients. Ten 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.

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 2400 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female =18 years of age at time of screening, weight=35kg.

• Diagnosed with rheumatoid arthritis satisfying the 1987 American College of Rheumatology classification criteria.

• Stable treatment including DMARDs (Disease Modifying Anti-Rheumatic Drugs), the doses had been stable for at least 3 months before baseline

• Have given written informed consent

Exclusion Criteria:

• Patient presenting or having a history of other inflammatory joint disease

• 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 infection 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 to participate 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 become 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, as known by serum creatinine > 133µmol/L (or 1.5 mg/dl)

• 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, abciximab, Belimumab or rituximab within 3 months prior to the first dose of treatment.

• Patient whose BMI(body mass index) under 18.5 kg/m2 or more than 30 kg/m2

• Patient with history of drug or alcohol abuse

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Sodium Butyrate
2 capsules butyrate supplement once a day for 12 weeks

Locations

Country	Name	City	State
China	Department of Rheumatology and Immunology, Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T-cell subtypes	Evaluating changes of percentage of T-cell subtypes, especially T regulatory cells (Treg) in Peripheral Blood	12 weeks
Secondary	serum zonulin	Evaluating changes of zonulin concentration in serum.	12 weeks
Secondary	serum occludin	Evaluating changes of occludin concentration in serum.	12 weeks
Secondary	serum intestinal Fatty Acid Binding Protein	Evaluating changes of intestinal Fatty Acid Binding Protein(i-FABP) concentration in serum.	12 weeks
Secondary	serum Lipopolysaccharide-binding protein	Evaluating changes of Lipopolysaccharide-binding protein concentration in serum.	12 weeks
Secondary	serum tight junction protein 1	Evaluating changes of tight junction protein 1 concentration in serum.	12 weeks
Secondary	Faecal microbiome	Evaluating changes of faecal microbiome profiling by amplicon sequencing	12 weeks
Secondary	Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28-ESR)	Evaluating changes of the DAS28 index, which was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and erythrocyte sedimentation rate value. A positive change in score indicates worsening, and a negative change indicates improvement. The score ranges from 0 to ca. 10 points, with > 5.1 indicating high disease activity, < 3.2 indicating low disease activity, and < 2.6 indicating clinical remission. Change from baseline to Week 12 will be used for the confirmation of therapeutic similarity.	12 weeks
Secondary	Rate of participants with adverse effects associated with experimental drugs	Adverse effects include fever, rash, abnormal liver and kidney function, rate of new-onset infection and any abnormal measures associated with experimental drugs.	12 weeks