1.Evaluation of Efficacy and Tolerability of Fixed Dose Combination of Rifaximin and Metronidazole in the Management of Irritable Bowel Syndrome with Diarrhea
Arif A Faruqui ; Shaguphta T Shaikh ; Faaria Ali
Pacific Journal of Medical Sciences 2025;26(1):34-40
Irritable bowel syndrome, a prevalent functional bowel disorder, significantly affects patients' everyday
lives and imposes a substantial economic burden on society. However, treatments options for managing
diarrhea-predominant irritable bowel syndrome are limited. Rifaximin along with metronidazole is
proposed as a treatment option for irritable bowel syndrome with diarrhea. The aim of this study was to
evaluate the efficacy and tolerability of a fixed dose combination of rifaximin and metronidazole in the
management of irritable bowel syndrome with diarrhea. An open-label, non-comparative, non-
randomized, multicentre trial was conducted in 25 subjects presenting with acute diarrheal episodes
associated with irritable bowel syndrome. The study was approved by institutional research ethics
committee and participants provided signed informed consent. Patients were given fixed dose
combination tablet containing rifaximin 200mg and metronidazole 400mg twice daily for 5 days.
2.Post Marketing Observational Study of Fixed Dose Combination of Rifaximin and Metronidazole in the Management of Acute Diarrhea In Children
Arif A Faruqui ; Shaguphta T Shaikh
Pacific Journal of Medical Sciences 2025;26(2):34-40
Acute diarrhea is a frequent illness in children, especially in developing nations, posing risks of
dehydration, malnutrition, and even death. Recently, there's been rising interest in Rifaximin and
Metronidazole Fixed Dose Combination (FDC) as a treatment option for pediatric acute diarrhea. The
aim of this study was to evaluate the efficiency and tolerability of rifaximin and metronidazole fixed-dose combination in the management of acute diarrhea in children. This was a multicenter, open-label, non- comparative, and non-randomized trial that enrolled 80 patients (age <18 years) experiencing acute diarrhea caused by various factors. This observational study was conducted post-approval of drugs by state Food and Drug Administration (FDA), therefore informed consent and ethics approval were not mandatory. Patients received suspension containing 100mg rifaximin and 200mg metronidazole per 5ml, twice daily for 5 days based on body weight. The primary endpoint assessed was change in frequency of loose/watery stools, fever, nausea, vomiting, abdominal pain, and gas/flatus from baseline to day 5.

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