Therapeutic effect of ursodeoxycholic acid on duodenal permeability and meal related sensory motor function in functional dyspepsia patients - UDC trial

niversitaire ziekenhuis Leuven0 个研究点目标入组 0 人开始时间: 2016年12月6日最近更新: 2021年3月17日

试验速览

暂无简介。

•a. Patient has functional dyspepsia, defined by the Rome III criteria. The patient must have at least one cardinal symptom for the last 3 months,
•with symptom onset at least 6 months prior to screening and in the
•absence of organic, metabolic or systemic diseases that can explain
•these symptoms.
•b. Patient has to discontinue intake of proton pump inhibitors, NSAIDs and drugs effecting gastric motility for 14 weeks. They have to replace oral anticonception with non-oral anticonception.
•c. Women need to use non-oral anticonception
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 16
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•a. Patient is under the age of legal consent.
•b. Female patients who are pregnant or breastfeeding.
•c. Patient is allergic to bile acids
•d. Patient has active stomach or gut ulcer, liver or bowel disorders
•e. Patient has biliary colic, calcified gallstones, not well functioning gall bladder, obstruction of gallbladder and acute inflammation of gallbladder
•f. Patient is gluten intolerant, lactose intolerant, diabetes mellitus, Crohn's disease, ulcerative colitis, allergy (asthma, eczema, allergic to bile acids), problems with coagulation.
•g. Patient with first degree family members with gluten intolerance, Crohn's disease or diabetes mellitus.
•h. Severe kidney malfunction
•i.Intake of Intake of oral anticonception, barbiturates, antacid, colestyramine or colestipol, nitrendipine , cyclosporine, ciprofloxacine, rosuvastatine and PPIs, NSAIDs and drugs effecting gastric motility.

发起方

niversitaire ziekenhuis Leuven