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

NCT06166615 | Unknown Phase 2

• 1 other identifier: H-2303-158-1417
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Does Ramosetron improve the symptoms of fecal incontinence?
2. 2.Is Ramosetron superior to Psyllium in terms of symptom improvement and its impact on quality of life?

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• Difference of Fecal Incontinence Severity Index

  This outcome measure assesses the difference in Fecal Incontinence Severity Index (FISI) scores in patients with fecal incontinence before and after treatment. The FISI questionnaire, used in previous studies, will be utilized to compare the scores pre- and post-medication for both the Ramosetron group and the Psyllium Agio® group. Details about the FISI Scale: Unabbreviated Scale Title: Fecal Incontinence Severity Index (FISI) Scale Range: The FISI scale typically ranges from 0 to a maximum value 61. Interpretation of Scores: Higher scores on the FISI scale indicate a worse outcome, reflecting greater severity of fecal incontinence symptoms.

  The FISI scores will be assessed at two time points - at baseline (prior to the initiation of treatment) and at 1 month post-treatment initiation.

Secondary Outcomes (3)

• Difference in Fecal Incontinence Severity Index (FISI) Scores Between the Two Groups

  Measured at baseline and 1-,4-, and 12-month.

• Fecal Incontinence Quality of Life Scale (FIQL) Scores Comparison

  Measured at baseline and 1-,4-, and 12-month.

• Bristol Stool Scale Scores Comparison

  Measured at baseline and 1-,4-, and 12-month.

Study Arms (2)

Pyllium group

ACTIVE COMPARATOR

Take 2 sachets (12 g) orally once daily. Increase or decrease the dose as needed to treat your symptoms, with a maximum daily dose of 18 grams (6 grams in the morning and 12 grams in the evening). Do not chew this medication and take it with 1 to 2 cups of water. Take it for 1 month

Drug: Psyllium

Ramosetron group

EXPERIMENTAL

Men: 5 μg orally once daily. Increase or decrease the dose as needed based on symptoms, with a minimum daily dose of 2.5 μg and a maximum daily dose of 10 μg. Women: 2.5 μg orally once daily. Women: 2.5 μg orally once daily, titrated up or down as needed, with a maximum daily dose of 5 μg. Take it for 1 month

Drug: Ramosetron

Interventions

Ramosetron DRUG

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.

Ramosetron group

Psyllium DRUG

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.

Pyllium group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with fecal incontinence (patients with 2 or more symptoms of fecal incontinence per month for at least 3 months).
• Patients who are able to understand and comply with this study.
• Individuals who are agreeable to being on contraception for the duration of the study.

You may not qualify if:

• Patients who have difficulty swallowing medications
• Patients with gastrointestinal deformities due to surgery
• Patients with malabsorption
• Patients with inflammatory bowel disease (IBD)
• Patients undergoing treatment for cancer of the gastrointestinal tract
• Patients who are allergic to the study drug
• Patients with overflow incontinence and fecal impaction on rectal residual examination (DRE) or Bristol Stool Scale of 3 or less.
• Patients taking medication for fecal incontinence within 1 month of study entry.
• Pregnant or lactating women.
• Patients with contraindications to any of the study drugs (i.e., intestinal obstruction, intestinal stones, acute abdomen, undiagnosed abdominal pain/nausea/vomiting, gastrointestinal stenosis and dysphagia, patients with megacolon syndrome, severe diabetes, etc.).
• Patients taking an agent that is contraindicated in combination with either study drug.
• Patients deemed by the investigator and staff to be unsuitable for participation in the study.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Related Publications (6)

• Scarlett Y. Medical management of fecal incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S55-63. doi: 10.1053/j.gastro.2003.10.007.

  PMID: 14978639 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.

  PMID: 25022811 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.

  PMID: 23757096 BACKGROUND

• 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.

  PMID: 26347971 RESULT

• 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.

  PMID: 33982068 RESULT

• 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.

  PMID: 41194155 DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Interventions

ramosetron; Psyllium

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Rumi Shin, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rumi Shin, MD, PhD

CONTACT

+82-2-870-3295; roomie79@gmail.com

Seung Bum Ryoo, MD, PhD

CONTACT

sbryoomd@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: December 12, 2023
• Study Start: December 15, 2023
• Primary Completion: May 30, 2024
• Study Completion: November 1, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share