Effect of supplementation in treatment of patients with rheumatoid arthritis

Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in patients with rheumatoid arthritis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201511015623N58

Enrollment

Registered

2015-11-20

Start date

2015-09-29

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

Rheumatoid arthritis. Other streptococcal arthritis and polyarthritis

Interventions

Intervention 1: Intervention group: Probiotic capsule containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), d

Eligibility

Sex/Gender

All

Age

25 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients with rheumatoid arthritis Aged 25 to 70 years

Exclusion criteria

Exclusion criteria: Chronic renal failure Renal tubular acidosis or pancreatitis Patients likely to be started on biological agents Pregnant or lactating women Patients who are unable to read numbers and/or unable to mark the pain scale Patients unlikely to come for follow-up in the following 3 months

Design outcomes

Primary

Measure	Time frame
Hs-CRP. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;DAS-28. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Sum scores.	—

Secondary

Measure	Time frame
Insulin. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit.;Triglycerides. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Total antioxidant. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Insulin resistance. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit.;Fasting blood sugar. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;VLDL. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.	—

Measure

Time frame

Insulin. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit.;Triglycerides. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Total antioxidant. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Insulin resistance. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit.;Fasting blood sugar. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;VLDL. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5546 3378

Outcome results

None listed

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