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Fecal IncontinencePhase 2/3SERAFINCT06166615

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

A Phase 2/3 study testing Ramosetron and Psyllium in people with Fecal Incontinence, run by Seoul National University Hospital at 3 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This multicenter clinical trial evaluates ramosetron and psyllium for adults with fecal incontinence, which is the accidental loss of stool. Participants are randomly assigned to take either ramosetron or psyllium by mouth for one month. Participants and treating clinicians know which treatment is given. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Fecal Incontinence
What is being tested?
Ramosetron and Psyllium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
3 sitesSouth Korea
Study dates
19 Jan 2024to 30 Dec 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • SMG-SNU Boramae Medical Center

    Seoul, 07061

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

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)

This multicenter clinical trial evaluates ramosetron and psyllium for adults with fecal incontinence, which is the accidental loss of stool. Participants are randomly assigned to take either ramosetron or psyllium by mouth for one month. Participants and treating clinicians know which treatment is given.

The study assesses whether fecal incontinence symptoms improve from before treatment to one month after treatment begins in each group, using the Fecal Incontinence Severity Index (FISI). The study also compares changes between the groups and assesses quality of life and stool consistency. Longer-term follow-up is ongoing.

Being tested
Ramosetron, Psyllium
Medical subject headings
Fecal Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RamosetronDrug

    Ramosetron (a 5-HT3 receptor antagonist) has been developed as an effective treatment for irritable bowel syndrome-diarrhea (IBS-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.

  • PsylliumDrug

    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.

Study groups in NCT06166615
Study groupRoleWhat they receive
Psyllium groupActive comparatorTake 2 sachets (12 g) orally once daily in the morning for 1 month. Increase or decrease the dose as needed to treat symptoms, with a maximum daily dose of 18 g (6 g in the morning and 12 g in the evening). Do not chew the granules; take with 1 to 2 cups of water.
Receives: Drug: Psyllium
Ramosetron groupExperimentalMen: Start at 5 μg orally once daily in the morning, with dose adjustment as needed from 2.5 to 10 μg/day. Women: Start at 2.5 μg orally once daily in the morning, with dose adjustment as needed up to a maximum of 5 μg/day. Treatment duration: 1 month.
Receives: Drug: Ramosetron

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in total Fecal Incontinence Severity Index (FISI) from baseline to 1 month

    Within each treatment arm, change in total Fecal Incontinence Severity Index (FISI) score from baseline to 1 month after treatment initiation. FISI is a patient-reported measure of the type and frequency of fecal incontinence. Total scores range from 0 to 61; higher scores indicate greater severity. A decrease from baseline indicates improvement.

    Measured: 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)

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

    Between-group comparison of the change in total Fecal Incontinence Severity Index (FISI) score from baseline in the ramosetron and psyllium groups. FISI scores range from 0 to 61; higher scores indicate greater fecal incontinence severity. A decrease from baseline indicates improvement.

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

  2. 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.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 domain scores indicate better fecal incontinence-related quality of life.

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2023
  2. Study start19 Jan 2024
  3. Primary completion31 May 2025
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, two-arm, parallel-group, active-comparator trial. Participants are randomized 1:1 using a computer-generated sequence with permuted blocks of 4 and 6, stratified by sex.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06166615
Sponsor's protocol ID
H-2303-158-1417
Acronym
SERAFI
Status last verified
Oct 2026
First submitted
29 Oct 2023
Last updated
27 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41194155

  • 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.

    PubMed 26347971

  • 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.

    PubMed 33982068

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

    PubMed 14978639

  • 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.

    PubMed 25022811

  • 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.

    PubMed 23757096

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ramosetron and Psyllium in people with Fecal Incontinence, run by Seoul National University Hospital at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in total Fecal Incontinence Severity Index (FISI) from baseline to 1 month (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06166615, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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