Ebastine Versus Mebeverine in IBS Patients

Launched by GUY BOECKXSTAENS · Apr 4, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two medications, ebastine and mebeverine, to see which one works better for treating irritable bowel syndrome (IBS) in patients who do not have constipation as their main symptom. The goal is to find out if ebastine, which affects histamine receptors, can provide better relief from abdominal pain and improve quality of life compared to mebeverine, a commonly used treatment for IBS.

To participate in the trial, you need to be between 18 and 65 years old and have symptoms of IBS that fit specific criteria. You should not have any other serious health conditions, and your symptoms should not be caused by other diseases like coeliac disease or inflammatory bowel disease. If you join the study, you will receive one of the two treatments, and researchers will monitor your progress to understand how well each medication works. This trial is currently recruiting participants, and your involvement could contribute to important findings for IBS treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• • 2. Patients fulfilling the Rome IV criteria for non-constipated IBS (IBS-C subtypes will be excluded)
• • 3. No organic cause that can explain the presenting symptoms (exclusion of coeliac disease (blood), lactose intolerance (breath test), inflammatory bowel disease and giardiasis (stool)
• • 4. Patients with lactose intolerance can be included if no improvement on lactose free diet during 6 weeks
• • 5. Age 18-65
• Exclusion Criteria:
• • 1. History of coeliac disease, food allergy, giardiasis, inflammatory bowel disease, infectious gastroenteritis, motility disorder, serious liver kidney cardiac or pulmonary disease, known cardiac rhythm disorders, insuline-dependent diabetes, psychiatric diseases
• • 2. Pregnancy, breast feeding
• • 3. Medication: the use of antidepressants or antipsychotics, anti-allergic medication or drugs affecting gastrointestinal motility / visceral sensitivity (anti-cholinergics, antispasmodics, 5-HT3 antagonists, 5-HT4 agonists, loperamide, codeine, laxatives, analgesics: only paracetamol is allowed as analgetic, other analgesics are forbidden.), CYP3A4-inducing and inhibiting drugs. Potent inhibitors of CYP3A4 include clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal and grapefruit. Inducers of CYP3A4 include phenobarbital, phenytoin, rifampicin, St. John's Wort and glucocorticoids.
• • 4. Symptoms started following abdominal surgery
• • 5. IBS constipation dominant (IBS-C)
• • 6. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC of the respective medicinal products