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Effects of a combination treatment using probiotics and methotrexate (MTX) in patients with rheumatoid arthritis

Effects of a combination treatment using probiotics and methotrexate (MTX) in patients with rheumatoid arthritis - Effects of a combination treatment using probiotics and MTX

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004052
Enrollment
40
Registered
2010-08-23
Start date
2010-08-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

rheumatoid arthritis

Interventions

Probiotics administration group: oral administration of 3g a day of probiotics to RA patient Non probiotics administration group: Continue conventional therapy without administration of probiotics.

Sponsors

Center for Rheumatic Diseases,Yokohama City University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients who are diagnosed with RA according to the ACR criteria 2.RA patients treated with MTX 3.Patients who agreed not to undertake major changes of therapy for RA during the administration period 4.Patients at the age of 16 or older

Exclusion criteria

Exclusion criteria: 1.Patients with allergy to milk or foods which contain lactobacillus 2.Patients with critical complications in heart, kidney, liver, and blood disorder 3.Patients treated with biologics 4.Patients considered to be ineligible by the responsible researcher or assigned researcher

Design outcomes

Primary

MeasureTime frame
Improvement of DAS28 score before administration, and at 1, 4, 12, 24 weeks after administration

Secondary

MeasureTime frame
Improvement of mHAQ and VAS before administration, and at 1, 4, 12, 24 weeks after administration Investigation of adverse events, clinical examination values, and the titer of anti-E-coli antibody

Countries

Japan

Contacts

Public ContactKatsushi Ishii

Yokohama City University Medical Center Center for Rheumatic Diseases

ishi69@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026