Effect of supplementation in treatment of patients with rheumatoid arthritis

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201611165623N94

Enrollment

Registered

2016-11-18

Start date

2016-08-08

Completion date

Unknown

Last updated

2019-10-07

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: Synbiotic capsule containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g),

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: Patients who had chronic renal failure Pregnant Lactating women Symptoms or personal history of cardiovascular disease, diabetes mellitus The consumption of antihyperglycemic agents Patients unlikely to come for follow-up in the following 3 months Patients who are unable to read numbers and/or unable to mark the pain scale Taking probiotics, synbiotics, antioxidant and/or anti-inflammatory supplements Taking antibiotics

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.;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.;Triglycerides. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin resistance. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Calculation using HOMA formula.	—

Measure

Time frame

Insulin. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa 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.;Triglycerides. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin resistance. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Calculation using HOMA formula.

—

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