Ebastine for adults with diarrhea-predominant IBS
Effect of Ebastine in Patients With Diarrhea Predominant Irritable Bowel Syndrome
PHASE2; PHASE3 · Dhaka Medical College · NCT07114055
This will test whether taking ebastine at night helps adults with diarrhea-predominant IBS reduce their symptoms compared with a placebo.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dhaka Medical College (other) |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT07114055 on ClinicalTrials.gov |
What this trial studies
This Phase 2/3 interventional trial compares nightly ebastine 20 mg to a matching placebo in adults who meet Rome IV criteria for diarrhea-predominant IBS. Participants take study medication once daily for 8 weeks alongside lifestyle modifications and are evaluated at baseline, week 4, and week 8 using the IBS Symptom Severity Score (IBS-SSS). Patient-reported adverse events are recorded throughout the treatment period to monitor safety. The study is conducted at Dhaka Medical College and enrolls adults aged 18 and over without alarm features or major comorbid conditions.
Who should consider this trial
Good fit: Adults aged 18 and older who meet Rome IV criteria for diarrhea-predominant IBS, are not pregnant or lactating, and do not have alarm signs or major gastrointestinal or uncontrolled endocrine diseases.
Not a fit: People with alarm features, prior major GI surgery, uncontrolled diabetes or thyroid disease, pregnant or breastfeeding women, vehicle/mechanical/aerial operators, or those with substance abuse are excluded and would not be expected to benefit from this tested approach.
Why it matters
Potential benefit: If successful, ebastine could provide a new medication option to reduce diarrhea and abdominal symptoms in people with IBS-D.
How similar studies have performed: Using an antihistamine like ebastine for IBS-D is a relatively novel approach with limited prior clinical evidence supporting benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Age 18 and above * Patients who meet the Rome IV criteria for IBS-D. Exclusion criteria * 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
Where this trial is running
Dhaka
- Dhaka Medical College — Dhaka, Bangladesh (RECRUITING)
Study contacts
- Study coordinator: Md. Hazrat Ali, MBBS
- Email: mhalirmc45@gmail.com
- Phone: +8801710725424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Irritable Bowel Syndrome - Diarrhoea, Ebastine