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IRCT20121216011763N37 IRCT 2019-06-25 the University of medical sciences Esfahan Effect of symbiotic supplementation in rheumatoid arthritis Evaluation of symbiotic supplementation on the disease activity in rheumatoid arthritis 2019-03-02 anticipated 200 Complete https://irct.ir/trial/34461 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization sequence was generated using STATA 14 statistical software and was stratified with a 1:1 allocation using random block size of 2. Sex, MTX and prednisolone doses were involved in stratification. The Pts were assigned to the MTX-prednisolone based treatment strategy combined with either 1000 mg/day symbiotic supplement (MTX and prednisone PLUS symbiotic group), or placebo (MTX and prednisolone PLUS placebo group) groups following stratified randomization procedures. The symbiotic and placebo were in capsule forms and identical in shape, size, count and also, similar in the appearance of the opaque bottles in which drugs were prepared and numbered, by computer, for each patient. Then bottles were put in 2 black boxes by a "research-blinded rheumatology clinic secretary" to hide the sequence from the main researchers (Esmaili F. and Salesi M.) enrolling and assessing participants. To ensure adequate concealment from the researchers, drugs were administered to the patients by another "research-blinded rheumatology clinic secretary", after the subjects completed all baseline assessments and also, after they signed the informed consent. The statistical sequence of the classified blocks was prepared for the participants by Professor Merasi. The details of the series were unknown to the main investigators (Dr. Esmaili and Dr. Salesi). Main investigators enrolled the participants with ignorance to the allocation sequence and the drugs were put in to two boxes by a secretary and were administered by another, Blinding description: This study was a double-blind clinical trial (participant, researcher). The lactocare synbiotic supplement and its placebo, were produced by Zist takhmir company. Synbiotic supplement and its placebos were put in the same form of package and the patients and researcher were not aware of the content of the package until the end of trial. N/A Rheumatoid Arthritis. Intervention 1: Intervention group During the 3 months of our study, we used steroid and DMARD (methotrexate) and synbiotic. This supplement made by the Lactocare brand was made by the biomarker knowledge-based company. In the form of capsules of 500 mg contains 7 probiotic strains with a dose of one billion CFUs and prebiotic fructooligosaccharide. All probiotic strains of this supplement had positive effects on inflammatory control: Lacobacillus casei, Lacobacillus asidophilus, Lacobacillus rhmnosus, Lacobacillus bugaricus, Bifidobacterium breve, Bifidobacterium longun, Streptococcus thermophiles. How to administer supplements was that in 3 months Intervention: Two capsules were consumed every day after lunch. Intervention 2: Control group: Individuals over the course of 3 months, our study of steroids and DMARD (methotrexate) and placebo (containing starch) received two capsules daily after lunch. The placebo is made in the biomarker company and were be available to patients in the form of capsules of the same type as synbiotic. Yes - There is a plan to make this available What will be shared: The collected identified for the primary outcome measure only will be shared. When: starting 12 months after publication To whom: En Available for people working in academic institutions Conditions: En The data will provide for educational use Where to obtain: Dr.mansour salesi mansour1380@yahoo.com How to obtain: En The data will send as soon as possible, after receiving the request Comments:
public فرح اسماعیلی
Shohadaye Soffeh Ave.,Alzahra Hospital
Esfahan Iran (Islamic Republic of) 81366665 +98 31 3431 7469 dr.esmaili.270288@gmail.com Esfahan University of Medical Sciences scientific Mansour Salesi
Shohadai Soffeh Ave.,Alzahra hospital
Esfahan Iran (Islamic Republic of) 8166665 +98 31 3431 7469 Mansour1380@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 18 years 80 years Both 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 M05 Rheumatoid arthritis with rheumatoid factor Treatment - Other Placebo Intervention group During the 3 months of our study, we used steroid and DMARD (methotrexate) and synbiotic. This supplement made by the Lactocare brand was made by the biomarker knowledge-based company. In the form of capsules of 500 mg contains 7 probiotic strains with a dose of one billion CFUs and prebiotic fructooligosaccharide. All probiotic strains of this supplement had positive effects on inflammatory control: Lacobacillus casei, Lacobacillus asidophilus, Lacobacillus rhmnosus, Lacobacillus bugaricus, Bifidobacterium breve, Bifidobacterium longun, Streptococcus thermophiles. How to administer supplements was that in 3 months Intervention: Two capsules were consumed every day after lunch Control group: Individuals over the course of 3 months, our study of steroids and DMARD (methotrexate) and placebo (containing starch) received two capsules daily after lunch. The placebo is made in the biomarker company and were be available to patients in the form of capsules of the same type as synbiotic. 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. the University of medical sciences Esfahan Approved 2019-03-02 Isfahan univesity of medical sciences Isfahan, Hezarjirib street Isfahan Isfehan Iran (Islamic Republic of)