NCT06166615

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DRUG	Ramosetron	Ramosetron (a 5-HT3 receptor antagonist) has been developed as an effective treatment for irritable bowel syndrome-diarrhea (IBD-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.

Timeline

• Start date: 2023-12-15
• Primary completion: 2024-05-30
• Completion: 2024-11-01
• First posted: 2023-12-12
• Last updated: 2023-12-12