Health Condition 1: M259- Joint disorder, unspecified
Conditions
Interventions
Intervention1: Methotrexate plus Lactobacillus casei(Participants will receive standard methotrexate therapy as per treatment guidelines. Adjunct probiotic supplementation will be administered for a t
Sponsors
To be Determined (Funding Under Application)
Eligibility
Inclusion criteria
Inclusion criteria: Newly diagnosed patient of RA fulfilling the 2010 ACR/EULAR 2010 classification criteria for Rheumatoid arthritis. Patients who are treatment na ve. Patients aged between 20-40.
Exclusion criteria
Exclusion criteria: patient with gastrointestinal problems were excluded. patients with antibiotics. EGfr,45ml/min. patient with breast feeding and pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Disease Activity Score (DAS28-ESR/CRP) following methotrexate therapy and comparison between methotrexate alone versus methotrexate plus Lactobacillus casei supplementation.Timepoint: Change in DAS28 ESR or CRP Baseline prior to initiation of methotrexate therapy 3 months after methotrexate therapy 6 months for non responders receiving probiotic supplementation | — |
Secondary
| Measure | Time frame |
|---|---|
| Variation in disease activity (DAS28-CRP/ESR) between baseline and three months in patients with RA treated with methotrexate. Serum inflammatory markers (CRP ESR) changes after methotrexate treatment with and without probiotic supplementation. RUCAM scoring and liver function tests are used to evaluate the frequency and severity of methotrexate-related hepatotoxicity. Determine which gut microbial taxa are differentially abundant and linked to treatment toxicity and efficacy using 16S rRNA sequencing and statistical analysis. comparison of the safety and effectiveness results of methotrexate plus Lactobacillus casei versus methotrexate alone.Timepoint: Serum inflammatory markers TNF alpha IL 6 IL 10 CRP Baseline 3 months Liver function parameters ALT AST ALP Total Bilirubin Baseline Monthly monitoring up to 3 months End of 3 months Hepatic toxicity assessment using RUCAM Throughout treatment period Final assessment at 3 months Gut microbiota diversity and composition Baseline 3 months Relative abundance of Lactobacillus casei and key microbial taxa Baseline 3 months | — |
Countries
India
Contacts
Public ContactDr Deepalakshmi Mani
JSS College of Pharmacy
Outcome results
None listed