MedPath

The effects of probiotic supplementation on oxidative indices in women with rheumatoid arthritis

Phase 2
Conditions
Rheumatoid arthritis, unspecified
Rheumatoid Arthritis.
Registration Number
IRCT201207024105N10
Lead Sponsor
Vice chancellor for Research, Tabriz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

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
NameTimeMethod
Malondialdehyde. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Catalase. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Superoxide dismutase. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione peroxidase. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Serum total antioxidant capacity. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.
Secondary Outcome Measures
NameTimeMethod
Body Mass Index (BMI). Timepoint: At baseine and after 8 weeks of intervention. Method of measurement: Calculation based on the measured weight and height.;Calorie 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.
© Copyright 2025. All Rights Reserved by MedPath