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ACTIVE NOT RECRUITING
NCT06166615
PHASE2/PHASE3

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

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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