Irritable Bowel Syndrome - DiarrhoeaPhase 2/3NCT07114055
Effect of Ebastine in Patients With Diarrhea Predominant Irritable Bowel Syndrome
A Phase 2/3 study testing ebastine in people with Irritable Bowel Syndrome - Diarrhoea, run by Md. Hazrat Ali at 1 site in Bangladesh.
Trial summary
The goal of this clinical trial is to assess and compare the effect of ebastine and placebo in improving symptoms in patients with diarrhea predominant IBS. It will also assess about the safety of drugs ebastine and placebo by recording the patient reported adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome - Diarrhoea
- What is being tested?
- ebastine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- 15 Aug 2025to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and above
- Patients who meet the Rome IV criteria for IBS-D.
Who cannot join
- Presence of alarm features: anemia, weight loss, per rectal bleeding, nocturnal frequency, and family history of colonic cancer
- History of major gastrointestinal surgery
- Medical disease that affect the digestive system, such as uncontrolled diabetes, hyperthyroidism, hypothyroidism
- Pregnant and lactating women
- Vehicle drivers, mechanical operators and aerial operators
- Drug abuse or alcohol abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Dhaka Medical College
Dhaka
Md. Hazrat Ali, MBBS, +8801710725424, mhalirmc45@gmail.com
About this study
The goal of this clinical trial is to assess and compare the effect of ebastine and placebo in improving symptoms in patients with diarrhea predominant IBS. It will also assess about the safety of drugs ebastine and placebo by recording the patient reported adverse events. The main questions it aim to answer are:
Does drug ebastine and placebo has any effect on patients with IBS-D? What medical problems do participants have when taking drug ebastine and placebo? Researcher will compare effect of drug ebastine and placebo .
Read more
Participant will:
Take drug ebastine 20 mg at night and placebo once daily at night every day for 8 weeks along with lifestyle modifications. After that all two groups will visit the hospital 4 weekly, and their symptoms will be assessed by IBS symptom severity score (IBS-SSS) at baseline, week 4 and week 8. Additionally, patient reported adverse events will be documented.
- Conditions
- Irritable Bowel Syndrome - Diarrhoea
- Being tested
- ebastine, Placebo
- Keywords
- Ebastine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ebastineDrug
Tab. Ebastine 20mg once daily at night
PlaceboDrug
Tab. Placebo once daily at night
| Study group | Role | What they receive |
|---|---|---|
| Ebastine | Active comparator | Tab. Ebastine 20mg once daily at night Receives: Drug: ebastine |
| Placebo | Placebo comparator | Tab. Placebo once daily at night Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. 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 8 ]
Secondary outcomes (4)
The effect of ebastine 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 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 8
Compare the effect of ebastine 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 8
Adverse events
Patient reported adverse events will be documented
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start15 Aug 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome - DiarrhoeaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Md. Hazrat Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Md. Hazrat Ali, Dhaka Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114055
- Sponsor's protocol ID
- IRB-DMC/2025/52
- Status last verified
- Aug 2025
- First submitted
- 8 Jul 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ebastine in Patients With Diarrhea Predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT07114055
- Acronym / sponsor ID
- IRB-DMC/2025/52
- Conditions
- Irritable Bowel Syndrome - Diarrhoea
- Keywords
- Ebastine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Md. Hazrat AliUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 11 Aug 2025 (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.
The goal of this clinical trial is to assess and compare the effect of ebastine and placebo in improving symptoms in patients with diarrhea predominant IBS. It will also assess about the safety of drugs ebastine and placebo by recording the patient reported adverse events. The main questions it aim to answer are:
Does drug ebastine and placebo has any effect on patients with IBS-D? What medical problems do participants have when taking drug ebastine and placebo? Researcher will compare effect of drug ebastine and placebo .
Participant will:
Take drug ebastine 20 mg at night and placebo once daily at night every day for 8 weeks along with lifestyle modifications. After that all two groups will visit the hospital 4 weekly, and their symptoms will be assessed by IBS symptom severity score (IBS-SSS) at baseline, week 4 and week 8. Additionally, patient reported adverse events will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ebastine | Active comparator | Drug: ebastineTab. Ebastine 20mg once daily at night |
| Placebo | Placebo comparator | Drug: PlaceboTab. Placebo once daily at night |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 and above
- Patients who meet the Rome IV criteria for IBS-D.
Key exclusion criteria (6 listed)
- Presence of alarm features: anemia, weight loss, per rectal bleeding, nocturnal frequency, and family history of colonic cancer
- History of major gastrointestinal surgery
- Medical disease that affect the digestive system, such as uncontrolled diabetes, hyperthyroidism, hypothyroidism
- Pregnant and lactating women
- Vehicle drivers, mechanical operators and aerial operators
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 |
|---|---|---|
| ebastineTab. Ebastine 20mg once daily at night | Drug | Ebastine |
| PlaceboTab. Placebo once daily at night | Drug | Placebo |
Primary outcome
1. Improvement of diarrhea predominant IBS symptoms
Time frame: [At baseline before randomization and then at week 4, and 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 ebastine in diarrhea predominant IBS patients
Time frame: [At baseline before randomization and then at week 4, and 8]
The effect of placebo in diarrhea predominant IBS patients
Time frame: At baseline before randomization and then at week 4, and 8
Compare the effect of ebastine and placebo
Time frame: At baseline before randomization and then at week 4, and 8
Adverse events
Time frame: through study completion, an average of 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 20 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ebastine in people with Irritable Bowel Syndrome - Diarrhoea, run by Md. Hazrat Ali at 1 site in Bangladesh.
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 2 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: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. 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. 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 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?
Contact Md. Hazrat Ali, MBBS (+8801710725424, mhalirmc45@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Improvement of diarrhea predominant IBS symptoms (time frame: [At baseline before randomization and then at week 4, and 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 20 Aug 2025.