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

Fecal Incontinence Clinical Trial

Official title:
The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) Versus Psyllium (Agio®) for the Treatment of Fecal Incontinence: Multicenter Randomized Trial (SERAFI)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06166615
Study type Interventional
Source Seoul National University Hospital
Contact Rumi Shin, MD, PhD
Phone +82-2-870-3295
Email roomie79@gmail.com
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date December 15, 2023
Completion date November 1, 2024
View Details
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