Effect of symbiotic supplementation in rheumatoid arthritis

Not Applicable

Conditions: Rheumatoid Arthritis.
Rheumatoid arthritis with rheumatoid factor

Registration Number: IRCT20121216011763N37

Lead Sponsor: the University of medical sciences Esfahan

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 200

Inclusion Criteria

Rheumatoid arthritis patients (based on ACR criteria)
At least 3 months after the diagnosis of RA.
At least 4 swollen joints which were in a stable status for at least 1 month, on MTX and prednisolone

Exclusion Criteria

Drug reaction and hypersensitivity
patient dissatisfaction
consumption of probiotic oral or medical in the last 2 weeks
IBD
intestinal perforation
creatinine clearance by using the CKD-EPI equation of less than 40 mL/min per 1.73 m2
aspartate and alanine aminotransferase levels greater than twice the upper limit of normal
active or recent hepatitis or cirrhosis
plan for surgery in the next 3 months
thyroid disorders
Cushing's disease or syndrome
malignant tumors,
inadequately controlled diabetes mellitus or arterial hypertension
serious infections,
serious cardiac or respiratory diseases, leukopenia or thrombocytopenia,
inadequate contraception, pregnancy or a plan for it in the next 3 months, breastfeeding,
osteoporosis,
use of cytotoxic or immunosuppressive drugs for 3 months before inclusion,
current or past substance abuse (including tobacco) or alcohol use greater than 2 U/d
and psychological illnesses or intellectual disorders that would preclude adherence to the study protocol

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of disease activity. Timepoint: At the beginning of the study and 3 months after starting the drug. Method of measurement: Physical examination for the number of tender joint (T1) and swellen j (S1) and blood tests (ESR, CRP, ALT, Cr), calculate DAS28 according to ESR, Tender Joint, Sowllen joint and VAS dat.

Secondary Outcome Measures