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Antibiotic-probiotic therapy in early Rheumatoid Arthritis

An open label randomized controlled trial of short course antibiotic and probiotic therapy in treatment naive patients of rheumatoid arthritis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053478
Enrollment
30
Registered
2023-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement Health Condition 2: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement

Interventions

Intervention1: Doxycycline, Linezolid, Lactobacillus, Bifidobacteria (plus SOC): Once the diagnosis of rheumatoid arthritis is confirmed, the patients will be followed up at 6 and 12 weeks after givin

Sponsors

Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18yrs or more on the day of registration 2. Subjects diagnosed to be patient of Rheumatoid Arthritis according to 2010 ACOG-EULAR classification criteria who are treatment naive 3. Subjects willing to give signed informed consent 4. Subjects not on any anti-rheumatic treatment or DMARDs other than occasional NSAIDs

Exclusion criteria

Exclusion criteria: 1. Subjects who have received treatment for RA anytime or antibiotics in the last 6 weeks 2. Subjects with other inflammatory diseases which may act as confounders 3. Any significant co-existing/incapacitating chronic illness 4. Subjects on corticosteroids or any other immunosuppressive therapy 5. Subjects who are pregnant or reproductive couples who have intention of pregnancy

Design outcomes

Primary

MeasureTime frame
Change in DAS 28 CRP at 6 and 12 weeksTimepoint: 6 and 12 weeks

Secondary

MeasureTime frame
Any untoward effect or hypersensitivity reactionTimepoint: At 1 and 2 week

Countries

India

Contacts

Public ContactDrSusmita Das

Institute of Medical Sciences, BHU

dgautam@bhu.ac.in6392194981

Outcome results

None listed

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