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The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence
Sponsor: Seoul National University Hospital
Summary
This multicenter clinical trial evaluates ramosetron and psyllium for adults with fecal incontinence, which is the accidental loss of stool. Participants are randomly assigned to take either ramosetron or psyllium by mouth for one month. Participants and treating clinicians know which treatment is given. The study assesses whether fecal incontinence symptoms improve from before treatment to one month after treatment begins in each group, using the Fecal Incontinence Severity Index (FISI). The study also compares changes between the groups and assesses quality of life and stool consistency. Longer-term follow-up is ongoing.
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)
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
147
Start Date
2024-01-19
Completion Date
2026-12-30
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Ramosetron
Ramosetron (a 5-HT3 receptor antagonist) has been developed as an effective treatment for irritable bowel syndrome-diarrhea (IBS-D) and is used to decrease intestinal motility, stiffen stool consistency, and reduce the number of urgency bowel movements. Since one of the goals of treatment for fecal incontinence is the maintenance of stool consistency, this agent is expected to be effective in treating fecal incontinence.
Psyllium
Psyllium was found to be the most effective at improving symptoms of fecal incontinence among several dietary fibers in a randomized, controlled, single-blind study and is currently used as a first-line treatment for fecal incontinence.
Locations (3)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
SMG-SNU Boramae Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea