Rifaximin and Metronidazole Fixed Dose Combination: New Treatment Option in the Management of Diarrhea

Abstract

Background: Endemic infectious diarrhea is a widespread problem around the world, caused by a combination of viruses, bacteria, and parasites. While commonly used fluoroquinolone antibiotics are effective for specific types of acute diarrhea, they carry potential side effects. Aim: To assess the effectiveness and tolerability of a fixed-dose combination of rifaximin and metronidazole as an alternative treatment approach for the management of acute diarrhea. Study Design: A multicentre, open-label, non-comparative and non-randomized trial was conducted in 370 patients suffering from acute diarrhea due to various factors. Methodology: Patients were given a tablet containing fixed-dose combination of 200 mg of rifaximin and 400 mg of metronidazole twice daily for 5 days. The primary outcomes evaluated were changes in the number of loose/watery stools, the presence of fever, nausea, vomiting, abdominal pain and gas/flatulence from baseline to day 5. A global assessment using a 3-point scale (Excellent/Good/Poor) was done by the investigators for efficacy and tolerability evaluation. Adverse drug reactions were monitored throughout the study period. Results: After 5-day therapy, the average number of watery stools per day decreased significantly from 7.853 ± 3.773 to 0.766 ± 0.949 (P < .001). None of the patients experienced fever and vomiting, while few patients experienced nausea (0.31%), abdominal pain (0.31%), and gas/flatulence (0.93%) at the end of the study. According to the evaluation by the investigators, all patients reported good to excellent efficacy and tolerability. Conclusions: The combination therapy of rifaximin and metronidazole is clinically effective and safe to treat acute diarrhea caused by different factors and can serve as a new treatment option for managing acute diarrhea.