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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Fecal Incontinence Severity Index (FISI) Scores Between the Two Groups | This measure will assess the difference in FISI scores between the two treatment arms (Ramosetron group vs. Psyllium Agio® group). FISI Scale Details: Unabbreviated Scale Title: Fecal Incontinence Severity Index (FISI) Scale Range: 0-61 Score Interpretation: Higher FISI scores indicate worse fecal incontinence severity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rumi Shin, MD, PhD | Contact | +82-2-870-3295 | roomie79@gmail.com | |
| Seung Bum Ryoo, MD, PhD | Contact | sbryoomd@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rumi Shin, MD, PhD | Seoul National University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14978639 | Background | Scarlett Y. Medical management of fecal incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S55-63. doi: 10.1053/j.gastro.2003.10.007. | |
| 25022811 | 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. |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C071315 | ramosetron |
| D011620 | Psyllium |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 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. |
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| Measured at baseline and 1-,4-, and 12-month. |
| Fecal Incontinence Quality of Life Scale (FIQL) Scores Comparison | This outcome measure assesses the impact of fecal incontinence on patients' quality of life using the FIQL. The FIQL is a patient-reported outcome measure (PROM) that evaluates four domains of quality of life: lifestyle, coping/behavior, depression/self-perception, and embarrassment. It consists of 4 questions and 29 items, with various response categories and scoring methods. Scale Range: The FIQL does not provide an overall score, which complicates its use and interpretation.The FIQL includes a range of response options across its items, from 1 to 4 for most items, 1 to 5 for one item, and 1 to 6 for another. Lower scores indicate lower quality of life. Score Interpretation: Higher scores in specific domains (e.g., depression/self-perception) may indicate worse outcomes in those areas. | Measured at baseline and 1-,4-, and 12-month. |
| Bristol Stool Scale Scores Comparison | This measure will compare the Bristol Stool Scale scores between the two groups. Bristol Stool Scale Details: Unabbreviated Scale Title: Bristol Stool Scale Scale Range: 1-7 Score Interpretation: The scale classifies the form of human feces into seven categories. | Measured at baseline and 1-,4-, and 12-month. |
| 23757096 | 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. |
| 26347971 | Result | 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. |
| 33982068 | 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. |
| 41194155 | Derived | 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. |