[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guy Boeckxstaens\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100641374","study-evaluating-the-effect-of-ucb8600-on-mast-cell-activation-in-the-human-gut-100641374",false,"NCT07655375","Study Evaluating the Effect of UCB8600 on Mast Cell Activation in the Human Gut","MASTGUT","Inclusion Criteria group 1 (resection tissue from surgery patients = healthy volunteers):\n\n1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures\n2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)\n3. Undergoing surgery for colorectal cancer\n4. No preoperative radiotherapy or chemotherapy\n\nExclusion Criteria group 1 (resection tissue from surgery patients = healthy volunteers):\n\n1. Using antihistamines such as ebastine, cetirizine, desloratadine, … (non-exhautive list) at the moment of surgery\n2. Inflammatory bowel disease (IBD) or diverticulitis\n3. Diabetes or BMI ≥ 30 kg\u002Fm²\n4. Subject is legally incapacitated\n\nInclusion Criteria group 2 (rectal biopsies from IBS patients):\n\n1. Voluntary written informed consent of the subject has been obtained prior to any screening procedures\n2. At least 18 years of age and maximum age of 65 years of age at the time of signing the Informed Consent Form (ICF)\n3. Diagnosed with IBS\n\nExclusion Criteria group 2 (rectal biopsies from IBS patients):\n\n1. Subject has internal\u002Fexternal hemorrhoids at the moment of biopsy sampling.\n2. Using bloodthinners such as Acenocoumarol, Aspirine (acetylsalicylzuur), Apixaban (Eliquis), Clopidogrel (Plavix), Dabigatran (Pradaxa), Edoxaban (Lixiana), Rivaroxaban (Xarelto), warfarine (Marevan®) and Enoxaparine (Clexane), … (non-exhausative list).\n3. Using antihistamines such as ebastine, cetirizine, desloratadine, … (non-exhausative list) at the moment of biopsy sampling. These should be stopped 2 weeks prior to the biopsy sampling.\n4. Subject is legally incapacitated",true,"ALL","18 Years","65 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","Study evaluating the effect of UCB8600 on mast cell activation in the human gut:\n\nIBS is a disease characterized by abdominal pain and a change in stool. Treatment is limited to an adapted life style, dietary changes and medication to lessen cramps (spasmolytica), all of which have seen limited to no clinical success.\n\nRecently, we were able to demonstrate that mast cells play an active role in IBS symptoms. More specifically, they set histamine free when activated which heightens nerve sensitivity in the intestines which probably contributes to the abdominal pain. A new product called \"UCB8600\" is hypothesized to be able to counteract this by causing less mast cells to be activated. In this study we'll test this by administering UCB8600 on intestinal tissue and see if there is less mast cell activation. If the study produces good results, this new product could potentially be used as a treatment for IBS in the future.",[28],"IBS (Irritable Bowel Syndrome)",[30,31,32,33],"IBS","irritable bowel syndrome","UCB8600","mast cells","NOT_YET_RECRUITING","2026-06-18",{"date":37,"type":38},"2026-06-22","ACTUAL",{"date":40,"type":22},"2026-06",{"date":42,"type":22},"2028-04",{"name":44,"class":45},"Guy Boeckxstaens","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100501926","phase-3-ebastine-versus-mebeverine-in-ibs-patients-100501926","NCT05815602","Ebastine Versus Mebeverine in IBS Patients","Multicenter Randomized Controlled Clinical Trial Comparing Ebastine and Mebeverine as Treatment of Irritable Bowel Syndrome","Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n2. Patients fulfilling the Rome IV criteria for non-constipated IBS (IBS-C subtypes will be excluded)\n3. No organic cause that can explain the presenting symptoms (exclusion of coeliac disease (blood), lactose intolerance (breath test), inflammatory bowel disease and giardiasis (stool)\n4. Patients with lactose intolerance can be included if no improvement on lactose free diet during 6 weeks\n5. Age 18-65\n\nExclusion Criteria:\n\n1. 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\n2. Pregnancy, breast feeding\n3. Medication: the use of antidepressants or antipsychotics, anti-allergic medication or drugs affecting gastrointestinal motility \u002F 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.\n4. Symptoms started following abdominal surgery\n5. IBS constipation dominant (IBS-C)\n6. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC of the respective medicinal products",{"count":55,"type":22},200,[57],"PHASE3","Multicenter randomized controlled clinical trial comparing ebastine and mebeverine as treatment of irritable bowel syndrome\n\nTrial rationale\n\n1. To perform a randomized superiority trial comparing the clinical efficacy of ebastine and mebeverine\n2. To evaluate the impact of treatment with ebastine compared to mebeverine on quality of life and quality-adjusted life years\n\nPrimary objective To provide further evidence of the superiority of histamine 1 receptor antagonism as novel treatment for patients with non-constipated IBS, as compared to mebeverine, one of the spasmolytics currently used as first line treatment of IBS.\n\nSecondary objective(s) To provide evidence that the histamine 1 receptor antagonist ebastine is more effective in reducing abdominal pain compared to the commonly used antispasmodic mebeverine",[60,30],"IBS - Irritable Bowel Syndrome",[62,63,30,64],"ebastine","duspatalin","Irritable Bowel Syndrome","RECRUITING","2026-03-19",{"date":68,"type":38},"2026-03-23",{"date":70,"type":38},"2023-03-30",{"date":72,"type":22},"2028-01-01",{"name":44,"class":45},5,""]