The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence
NCT ID: NCT06166615
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2/PHASE3
148 participants
INTERVENTIONAL
2023-12-15
2024-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pyllium group
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
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.
Ramosetron group
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rumi Shin
Associate Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rumi Shin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Scarlett Y. Medical management of fecal incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S55-63. doi: 10.1053/j.gastro.2003.10.007.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-2303-158-1417
Identifier Type: -
Identifier Source: org_study_id