The effect of probiotic supplementation on lipid profile and arylesterase activity of paraoxonase enzyme in women with rheumatoid arthritis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201306264105N14

Enrollment

Registered

2013-07-10

Start date

2013-08-31

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis. Rheumatoid arthritis, unspecified

Interventions

Intervention 1: One 250 milligram capsule containing 10 (8) colony forming unit (CFU) Lactobacillus. casei each day, for 8 weeks. Intervention 2: One daily 250 milligram capsule not containing the pro

Treatment - Drugs

Placebo

One 250 milligram capsule containing 10 (8) colony forming unit (CFU) Lactobacillus. casei each day, for 8 weeks

One daily 250 milligram capsule not containing the probiotic bacteria for 8 weeks

Eligibility

Sex/Gender

Female

Age

20 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients diagnosed with rheumatoid arthritis, based on ACR criteria; having inactive to moderate rheumatoid arthritis; under treatment with DMARDs (Methotrexate, Hydroxychloroquine and Prednisolone less than 10 milligrams per day) and not receiving NSAIDs or cytokine inhibitors; stable medication for at least 3 month prior to the interventions; having body mass index (BMI) less than 40; willing to participate in the study; ages between 20 and 80. Exclusion criteria: pregnant and lactating women; hormone therapy or receiving oral contraceptives; having diabetes mellitus, thyroid disorders, kidney or hepatic diseases or Cushing's syndrome; having inflammatory bowel disease or other inflammatory disorders; having digestive tract disorders or lactose intolerance; Taking antioxidant, vitamin, fiber or omega-3 supplements 3 weeks prior to the interventions; using antibiotics a month prior to the interventions; being on a weight reduction diet; smoking or being exposed to cigarette smoke; using other probiotic products.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Triglyceride. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Total cholesterol. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;HDL cholesterol. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;LDL cholesterol. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Friedewald equation.;Arylesterase activity of paraoxonase enzyme. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.	—

Measure

Time frame

Triglyceride. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Total cholesterol. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;HDL cholesterol. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;LDL cholesterol. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Friedewald equation.;Arylesterase activity of paraoxonase enzyme. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.

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Countries

Iran (Islamic Republic of)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026