Phase
Condition
Colic
Gastrointestinal Diseases And Disorders
Lactose Intolerance
Treatment
Duspatalin
Ebastine
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntary written informed consent of the participant or their legally authorizedrepresentative has been obtained prior to any screening procedures
Patients fulfilling the Rome IV criteria for non-constipated IBS (IBS-C subtypeswill be excluded)
No organic cause that can explain the presenting symptoms (exclusion of coeliacdisease (blood), lactose intolerance (breath test), inflammatory bowel disease andgiardiasis (stool)
Patients with lactose intolerance can be included if no improvement on lactose freediet during 6 weeks
Age 18-65
Exclusion
Exclusion Criteria:
History of coeliac disease, food allergy, giardiasis, inflammatory bowel disease,infectious gastroenteritis, motility disorder, serious liver kidney cardiac orpulmonary disease, known cardiac rhythm disorders, insuline-dependent diabetes,psychiatric diseases
Pregnancy, breast feeding
Medication: the use of antidepressants or antipsychotics, anti-allergic medicationor 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, otheranalgesics are forbidden.), CYP3A4-inducing and inhibiting drugs. Potent inhibitorsof CYP3A4 include clarithromycin, erythromycin, diltiazem, itraconazole,ketoconazole, ritonavir, verapamil, goldenseal and grapefruit. Inducers of CYP3A4include phenobarbital, phenytoin, rifampicin, St. John's Wort and glucocorticoids.
Symptoms started following abdominal surgery
IBS constipation dominant (IBS-C)
Hypersensitivity to the active substance or to any of the excipients listed insection 6.1 of the SmPC of the respective medicinal products
Study Design
Connect with a study center
AZ St-Maarten
Mechelen, Antwerpen 2800
BelgiumActive - Recruiting
UZLeuven
Leuven, Vlaams-Brabant 3000
BelgiumActive - Recruiting
AZ St-Lucas
Brugge, West-Vlaanderen 8310
BelgiumActive - Recruiting
GZA
Antwerpen, 2000
BelgiumActive - Recruiting
UZA
Antwerpen, 2000
BelgiumActive - Recruiting
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