IBS-D (Diarrhea-predominant)Phase 4NCT07574320
Effect of Ramosetron in Patients With Diarrhea Predominant Irritable Bowel Syndrome
A Phase 4 study testing Ramosetron 2.5 microgram in people with IBS-D (Diarrhea-predominant), run by Md. Aminul Islam.
Trial summary
Irritable bowel syndrome (IBS) tends to be a lifelong disorder and it is often frustrating to both patients and physicians. This study aim of improving symptom control, reducing healthcare burden and upgrading the quality of life of patient with diarrhea predominant IBS-D. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBS-D (Diarrhea-predominant)
- What is being tested?
- Ramosetron 2.5 microgram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2026to 1 Feb 2027
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years.
- Patients fulfilling Rome IV diagnostic criteria for IBS-D.
- Willing to provide informed written consent.
- Patients able to attend regular follow-up visits during the study period.
Who cannot join
- Presence of alarm features: anemia, weight loss, per rectal bleeding, nocturnal frequency, and family history of colonic cancer or inflammatory bowel disease
- History of major gastrointestinal surgery (excluding appendicitis )
- Recent antibiotic use within 4 weeks
- Patient with uncontrolled diabetes, hyperthyroidism, hypothyroidism
- Pregnant or lactating women
- Drug abuse or alcohol abuse
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Ramosetron in Patients With Diarrhea Predominant Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study
Irritable bowel syndrome (IBS) tends to be a lifelong disorder and it is often frustrating to both patients and physicians. This study aim of improving symptom control, reducing healthcare burden and upgrading the quality of life of patient with diarrhea predominant IBS-D.
Patients of both sex of age group 18-65 years attending gastroenterology outpatient department Dhaka Medical College Hospital (DMCH) meeting the inclusion criteria of Diarrhea predominant irritable bowel syndrome (IBS-D) will be initially enrolled for the study. Their history, clinical examination \& initial investigations will be done. Report will be noted in the standard data sheet. Any alternative diagnosis if proven by clinical examination or laboratory investigation will be excluded from the study.
Read more
Each patient will go through a run-in period of 7 days. Number of subjects will be recruited according to sample size. Randomization into two groups will be performed by online randomizer websites.
One group will receive tablet ramosetron 2.5 mcg one time daily at morning before breakfast while the other group will receive identical looking placebo one tablet once daily at same time. Both groups will be adviced for low FODMAP diet along with lifestyle modification. The tablets will be administered for total 4 weeks. Before starting treatment, each individual will undergo a baseline assessment during which demographic data, base line investigations, IBS symptoms by IBS Symptom Severity Score (IBS-SSS) will be recorded. Patients will be followed-up after 4 weeks and 8 weeks by IBS-SSS questionnaire. Any adverse effect will be reported quickly and documented at the same time.
IBS-SSS is a 5 item tools. It is primarily measures the IBS symptoms which includes abdominal pain and distension as well as bowel satisfaction. This scale evaluates IBS symptoms: abdominal pain, abdominal distension, stool frequency and consistency and interference with life in general. The IBS-SSS calculates the sum of these 5 items scored on a visual analogue scale from 0-100.
- Conditions
- IBS-D (Diarrhea-predominant)
- Being tested
- Ramosetron 2.5 microgram, Placebo
- Keywords
- IBS-D, Diarrhea Predominant Irritable Bowel Syndrome, Ramosetron, IBS-SSS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramosetron 2.5 microgramDrug
Ramosetron 2.5 microgram will be given in Group A
PlaceboDrug
Placebo will be given in Group C
| Study group | Role | What they receive |
|---|---|---|
| Ramosetron 2.5 microgram | Experimental | Group A - Ramosetron 2.5 microgram Receives: Drug: Ramosetron 2.5 microgram |
| Placebo | Placebo comparator | Group B - Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of diarrhea predominant IBS symptoms
The improvement of IBS symptoms will be assessed by IBS symptom severity score (IBS-SSS). This score is a Likert scale with seven domains divided into two parts. Part one is the severity score containing four domains, where domain one has two separate scoring scale. Each scale scoring from 0 to 100, that makes it a total score of 500. The severity is denoted as Mild (Score 75 to 175), Moderate (Score 176 to 300), and severe (Score more than 300). The part two is a descriptive questionnaire about bowel habit
Measured: At baseline before randomization and then at week 4 and week 8
Secondary outcomes (4)
The effect of ramosetron in diarrhea predominant IBS patients
The improvement of IBS symptoms will be assessed by IBS symptom severity score (IBS-SSS). This score is a Likert scale with seven domains divided into two parts. Part one is the severity score containing four domains, where domain one has two separate scoring scale. Each scale scoring from 0 to 100, that makes it a total score of 500. The severity is denoted as Mild (Score 75 to 175), Moderate (Score 176 to 300), and severe (Score more than 300). The part two is a descriptive questionnaire about bowel habit.
Measured: At baseline before randomization and then at week 4 and week 8
The effect of placebo in diarrhea predominant IBS patients
The improvement of IBS symptoms will be assessed by IBS symptom severity score (IBS-SSS). This score is a Likert scale with seven domains divided into two parts. Part one is the severity score containing four domains, where domain one has two separate scoring scale. Each scale scoring from 0 to 100, that makes it a total score of 500. The severity is denoted as Mild (Score 75 to 175), Moderate (Score 176 to 300), and severe (Score more than 300). The part two is a descriptive questionnaire about bowel habit.
Measured: At baseline before randomization and then at week 4 and week 8
Compare the effect of ramosetron and placebo
The improvement of IBS symptoms will be assessed by IBS symptom severity score (IBS-SSS). This score is a Likert scale with seven domains divided into two parts. Part one is the severity score containing four domains, where domain one has two separate scoring scale. Each scale scoring from 0 to 100, that makes it a total score of 500. The severity is denoted as Mild (Score 75 to 175), Moderate (Score 176 to 300), and severe (Score more than 300). The part two is a descriptive questionnaire about bowel habit.
Measured: At baseline before randomization and then at week 4 and week 8
Adverse events
Patient reported adverse events will be documented
Measured: through study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start30 Apr 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS-D (Diarrhea-predominant)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase IV investigator initiated trial with off label dose evaluation
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Md. Aminul Islam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Md. Aminul Islam, Dhaka Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574320
- Sponsor's protocol ID
- IRB-DMC/2025/259
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ramosetron in Patients With Diarrhea Predominant Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT07574320
- Acronym / sponsor ID
- IRB-DMC/2025/259
- Conditions
- IBS-D (Diarrhea-predominant)
- Keywords
- IBS-D, Diarrhea Predominant Irritable Bowel Syndrome, Ramosetron, IBS-SSS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Md. Aminul IslamUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Irritable bowel syndrome (IBS) tends to be a lifelong disorder and it is often frustrating to both patients and physicians. This study aim of improving symptom control, reducing healthcare burden and upgrading the quality of life of patient with diarrhea predominant IBS-D.
Patients of both sex of age group 18-65 years attending gastroenterology outpatient department Dhaka Medical College Hospital (DMCH) meeting the inclusion criteria of Diarrhea predominant irritable bowel syndrome (IBS-D) will be initially enrolled for the study. Their history, clinical examination \& initial investigations will be done. Report will be noted in the standard data sheet. Any alternative diagnosis if proven by clinical examination or laboratory investigation will be excluded from the study.
Each patient will go through a run-in period of 7 days. Number of subjects will be recruited according to sample size. Randomization into two groups will be performed by online randomizer websites.
One group will receive tablet ramosetron 2.5 mcg one time daily at morning before breakfast while the other group will receive identical looking placebo one tablet once daily at same time. Both groups will be adviced for low FODMAP diet along with lifestyle modification. The tablets will be administered for total 4 weeks. Before starting treatment, each individual will undergo a baseline assessment during which demographic data, base line investigations, IBS symptoms by IBS Symptom Severity Score (IBS-SSS) will be recorded. Patients will be followed-up after 4 weeks and 8 weeks by IBS-SSS questionnaire. Any adverse effect will be reported quickly and documented at the same time.
IBS-SSS is a 5 item tools. It is primarily measures the IBS symptoms which includes abdominal pain and distension as well as bowel satisfaction. This scale evaluates IBS symptoms: abdominal pain, abdominal distension, stool frequency and consistency and interference with life in general. The IBS-SSS calculates the sum of these 5 items scored on a visual analogue scale from 0-100.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Phase IV investigator initiated trial with off label dose evaluation
| Arm | Type | Receives |
|---|---|---|
| Ramosetron 2.5 microgram | Experimental | Drug: Ramosetron 2.5 microgramGroup A - Ramosetron 2.5 microgram |
| Placebo | Placebo comparator | Drug: PlaceboGroup B - Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-65 years.
- Patients fulfilling Rome IV diagnostic criteria for IBS-D.
- Willing to provide informed written consent.
- Patients able to attend regular follow-up visits during the study period.
Key exclusion criteria (6 listed)
- Presence of alarm features: anemia, weight loss, per rectal bleeding, nocturnal frequency, and family history of colonic cancer or inflammatory bowel disease
- History of major gastrointestinal surgery (excluding appendicitis )
- Recent antibiotic use within 4 weeks
- Patient with uncontrolled diabetes, hyperthyroidism, hypothyroidism
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramosetron 2.5 microgramRamosetron 2.5 microgram will be given in Group A | Drug | Ramosetron 2.5 microgram |
| PlaceboPlacebo will be given in Group C | Drug | Placebo |
Primary outcome
Improvement of diarrhea predominant IBS symptoms
Time frame: At baseline before randomization and then at week 4 and week 8
The improvement of IBS symptoms will be assessed by IBS symptom severity score (IBS-SSS). This score is a Likert scale with seven domains divided into two parts. Part one is the severity score containing four domains, where domain one has two separate scoring scale. Each scale scoring from 0 to 100, that makes it a total score of 500. The severity is denoted as Mild (Score 75 to 175), Moderate (Score 176 to 300), and severe (Score more than 300). The part two is a descriptive questionnaire about bowel habit
4 secondary outcomes
The effect of ramosetron in diarrhea predominant IBS patients
Time frame: At baseline before randomization and then at week 4 and week 8
The effect of placebo in diarrhea predominant IBS patients
Time frame: At baseline before randomization and then at week 4 and week 8
Compare the effect of ramosetron and placebo
Time frame: At baseline before randomization and then at week 4 and week 8
Adverse events
Time frame: through study completion, approximately 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ramosetron 2.5 microgram in people with IBS-D (Diarrhea-predominant), run by Md. Aminul Islam.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Dr. Md. Aminul Islam (+8801626299434, aminulthesis0950@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of diarrhea predominant IBS symptoms (time frame: At baseline before randomization and then at week 4 and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.