The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) Versus Psyllium (Agio®) for the Treatment of Fecal Incontinence: Multicenter Randomized Trial (SERAFI)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 148
- 主要终点
- Difference of Fecal Incontinence Severity Index
研究概览
简要总结
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:
- Does Ramosetron improve the symptoms of fecal incontinence?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Psyllium (Drug)
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
干预措施: Ramosetron (Drug)
结局指标
主要结局
Difference of Fecal Incontinence Severity Index
时间窗: 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.
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.
次要结局
- Bristol Stool Scale Scores Comparison(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.)
- Difference in Fecal Incontinence Severity Index (FISI) Scores Between the Two Groups(Measured at baseline and 1-,4-, and 12-month.)
研究者
Rumi Shin
Associate Professor of Medicine
Seoul National University Hospital