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अमूर्त

A Randomized Open Label Study to Evaluate the Efficacy and Tolerability of Synbiotic in the Treatment of Ulcerative Colitis

Malathi K, Nandini R, Dhanasekar KR, Shilpa BN*

Introduction: Ulcerative Colitis (UC) is a chronic inflammatory condition of the colon affecting 5 million patients globally. Despite the recent clinical advances in drug therapies, patients continue to have exacerbations of UC. Alterations in gut microbiota, more specifically reduced intestinal microbial diversity, have been found to be associated with relapse of UC. Therefore therapeutic strategy targeting the gut microbiota has the potential to induce remission in UC. This study was done to evaluate the efficacy and tolerability of synbiotic as an adjuvant to standard therapy in patients with UC and to evaluate the ability of synbiotic in preventing relapse and prolonging the remission of UC.
Methods: An interventional open label, randomized, comparative clinical trial was done with 32 patients. Patients were randomized into two groups, Study group (n=16) received synbiotic one capsule b.d along with standard therapy. Group B (n=16) received standard therapy only. Statistical analyses of the efficacy and safety parameters were done using chi square test paired t test and ANOVA.
Results: In our study, at the end of 6th month, statistically significant number of patients had remission in study group when compared to control group, with p<0.05. Significantly higher number of patients in control group had relapse compared to study group and also there was a statistically significant reduction in steroid intake in study group.
Conclusion: From this study we can conclude that synbiotic therapy along with standard treatment is effective in inducing and maintaining remission with a reduction in steroid dosage in UC and tolerable.