The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence

Summary

This clinical trial aims to assess the effectiveness of Ramosetron compared to Psyllium, a gold standard therapy, in patients with fecal incontinence. The primary questions it seeks to answer are: 1. Does Ramosetron improve the symptoms of fecal incontinence? 2. Is Ramosetron superior to Psyllium in terms of symptom improvement and its impact on quality of life? Participants will be randomly assigned to one of two groups, either taking Ramosetron or Psyllium for one month. They will be asked to complete a questionnaire. Researchers will then compare the Fecal Incontinence Severity Index between the Ramosetron and Psyllium groups to determine whether Ramosetron provides superior symptom relief compared to Psyllium.

Timeline

Start

2023-12-15

Primary completion

2024-05-30

Completion

2024-11-01

Publications

• Background Scarlett Y. Medical management of fecal incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S55-63. doi: 10.1053/j.gastro.2003.10.007.
• Background Wald A, Bharucha AE, Cosman BC, Whitehead WE. ACG clinical guideline: management of benign anorectal disorders. Am J Gastroenterol. 2014 Aug;109(8):1141-57; (Quiz) 1058. doi: 10.1038/ajg.2014.190. Epub 2014 Jul 15.
• Background Omar MI, Alexander CE. Drug treatment for faecal incontinence in adults. Cochrane Database Syst Rev. 2013 Jun 11;2013(6):CD002116. doi: 10.1002/14651858.CD002116.pub2.
• Results Markland AD, Burgio KL, Whitehead WE, Richter HE, Wilcox CM, Redden DT, Beasley TM, Goode PS. Loperamide Versus Psyllium Fiber for Treatment of Fecal Incontinence: The Fecal Incontinence Prescription (Rx) Management (FIRM) Randomized Clinical Trial. Dis Colon Rectum. 2015 Oct;58(10):983-93. doi: 10.1097/DCR.0000000000000442.
• Results Ryoo SB, Park JW, Lee DW, Lee MA, Kwon YH, Kim MJ, Moon SH, Jeong SY, Park KJ. Anterior resection syndrome: a randomized clinical trial of a 5-HT3 receptor antagonist (ramosetron) in male patients with rectal cancer. Br J Surg. 2021 Jun 22;108(6):644-651. doi: 10.1093/bjs/znab071.
• Park J, Ahn HM, Ryoo SB, Oh Y, Choi JS, Oh HK, Shin R. The Safety and Efficacy of Ramosetron versus Psyllium for the Treatment of Fecal Incontinence (SERAFI): Study protocol for a randomized, parallel, non-inferiority trial. Trials. 2025 Nov 5;26(1):471. doi: 10.1186/s13063-025-09165-2.

Drugs

Indications

No indication recorded.