The effects of probiotic supplementation on symptoms and inflammatory biomarkers in women with rheumatoid arthritis

Phase 2

• Conditions: Rheumatoid Arthritis.; Rheumatoid arthritis, unspecified

• Registration Number: IRCT201206234105N9
• Lead Sponsor: Vice chancellor for Research, Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1) Patients diagnosed with rheumatoid arthritis, based on ACR criteria; 2) Having inactive to moderate rheumatoid arthritis; 3) Under treatment with DMARDs (Methotrexate, Hydroxychloroquine and Prednisolone less than 10 milligrams per day) and not receiving NSAIDs or cytokine inhibitors; 4) Stable medication for at least 3 month prior to the interventions; 5) Having body mass index (BMI) less than 40; 6) Willing to participate in the study; 7) Ages between 20 and 80.
Exclusion criteria: 1) Pregnant and lactating women; 2) Hormone therapy or receiving oral contraceptives; 3) Having diabetes mellitus, thyroid disorders, kidney or hepatic diseases or Cushing's syndrome; 4) Having inflammatory bowel disease or other inflammatory disorders; 5) Having digestive tract disorders or lactose intolerance; 6) Taking antioxidant, vitamin, fiber or omega-3 supplements 3 weeks prior to the interventions; 7) Using antibiotics a month prior to the interventions; 8) Being on a weight reduction diet; 9) Smoking or being exposed to cigarette smoke; 10) Using other probiotic products.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease Activity Score (DAS-28). Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: calculation based on physical examination and serum hs-CRP.;Hs-CRP. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Immunoturbidimetry.;TNF-alpha. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: ELISA.;IL-1ß. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: ELISA.;IL-6. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: ELISA.;IL-10. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: ELISA.;IL-12. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: ELISA.;Visual Analogue Scale (VAS). Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Body Mass Index (BMI). Timepoint: At baseine and after 8 weeks of intervention. Method of measurement: Calculation based on the measured weight and height.;Calori and nutrient intake. Timepoint: At baseine and after 8 weeks of intervention. Method of measurement: One 24 hour dietary recall questionnaire and three dietary record questionnaires.;Systolic blood pressure. Timepoint: At baseine and after 8 weeks of intervention. Method of measurement: Stethoscope and sphyngomanometer.;Diastolic blood pressure. Timepoint: At baseine and after 8 weeks of intervention. Method of measurement: Stethoscope and sphyngomanometer.