Clinical trial NCT06166615: The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Fecal Incontinence
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 148
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients who have difficulty swallowing medications
2. Patients with gastrointestinal deformities due to surgery
3. Patients with malabsorption
4. Patients with inflammatory bowel disease (IBD)
5. Patients undergoing treatment for cancer of the gastrointestinal tract
6. Patients who are allergic to the study drug
7. Patients with overflow incontinence and fecal impaction on rectal residual examination (DRE) or Bristol Stool Scale of 3 or less.
8. Patients taking medication for fecal incontinence within 1 month of study entry.
9. Pregnant or lactating women.
10. 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.).
11. Patients taking an agent that is contraindicated in combination with either study drug.
12. Patients deemed by the investigator and staff to be unsuitable for participation in the study.

Primary outcomes:
measure: Difference of Fecal Incontinence Severity Index
timeFrame: 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:
measure: Difference in Fecal Incontinence Severity Index (FISI) Scores Between the Two Groups
timeFrame: Measured at baseline and 1-,4-, and 12-month.
measure: Fecal Incontinence Quality of Life Scale (FIQL) Scores Comparison
timeFrame: Measured at baseline and 1-,4-, and 12-month.
measure: Bristol Stool Scale Scores Comparison
timeFrame: Measured at baseline and 1-,4-, and 12-month.
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Rumi Shin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scarlett Y. Medical management of fecal incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S55-63. doi: 10.1053/j.gastro.2003.10.007.
citation: 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.
citation: 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.
citation: 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.
citation: 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.