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Effect of Ramosetron in Patients With Diarrhea Predominant Irritable Bowel Syndrome

4 mei 2026 bijgewerkt door: Md. Aminul Islam

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.

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

76

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Ramosetron 2.5 microgram
Group A - Ramosetron 2.5 microgram
Geneesmiddel: Ramosetron 2.5 microgram
Ramosetron 2.5 microgram will be given in Group A
Placebo-vergelijker: Placebo
Group B - Placebo
Geneesmiddel: Placebo
Placebo will be given in Group C

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Improvement of diarrhea predominant IBS symptoms
Tijdsspanne: 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
At baseline before randomization and then at week 4 and week 8

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The effect of ramosetron in diarrhea predominant IBS patients
Tijdsspanne: 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.
At baseline before randomization and then at week 4 and week 8
The effect of placebo in diarrhea predominant IBS patients
Tijdsspanne: 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.
At baseline before randomization and then at week 4 and week 8
Compare the effect of ramosetron and placebo
Tijdsspanne: 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.
At baseline before randomization and then at week 4 and week 8
Adverse events
Tijdsspanne: through study completion, approximately 1 year
Patient reported adverse events will be documented
through study completion, approximately 1 year

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Md. Aminul Islam

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 april 2026

Primaire voltooiing (Geschat)

1 januari 2027

Studie voltooiing (Geschat)

1 februari 2027

Studieregistratiedata

Eerst ingediend

22 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 mei 2026

Eerst geplaatst (Werkelijk)

7 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

4 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • IRB-DMC/2025/259

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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