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Effect of non-absorbable antibiotic, rifaximin in patients with irritable bowel syndrome: A single-center randomized controlled study

Bhagyalekshmi N, Ramesh M, Prathibha V K, J Xavier Ignatius.




Abstract
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Background: Irritable bowel syndrome (IBS), most common functional bowel disease, does not have a definite treatment. Studies revealed the involvement of bacterial overgrowth for its pathology. The aim of this study is to evaluate the effect of a non-absorbable antibiotic.

Aims and Objectives: The primary objective of the study is to assess the efficacy of a 14 days course of oral rifaximin at 400 mg thrice daily in patients with IBS without constipation. The secondary objective of this study is to evaluate the safety of a 14 days course of rifaximin at 400 mg thrice daily as compared with placebo in patients with IBS without constipation.

Materials and Methods: In this single-center, randomized, placebo-controlled study, we recruited patients, using Rome III criteria in 2 years. Treatment group received rifaximin 400 mg thrice daily for 2 weeks. All patients underwent symptom assessment and safety assessment before inclusion, at the end of the treatment and 1 week after the regimen. Primary endpoint (proportion of patients who achieved adequate relief of IBS symptoms) and Likert scales of symptoms of both groups were compared.

Results: Proportion of subject, who achieved adequate relief of IBS symptoms in the rifaximin arm, is more than placebo (68% vs. 39.1%). At the end of 2 weeks therapy, both groups show significant improvement in bloating score (P < 0.002), pain score (P < 0.001), and overall score (P < 0.002) and it continued for 1 more week. There were no significant adverse effects reported.

Conclusion: A 2 weeks course of 400 mg rifaximin thrice daily regimen provided a significant improvement in global IBS symptoms.

Key words: Irritable Bowel Syndrome; Rifaximin; Non-absorbable Antibiotic; Randomized Controlled Study






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