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Therapeutic Effect of Ursodeoxycholic Acid on Duodenal Permeability and Meal Related Sensory Motor Function in Functional Dyspepsia Patients

NCT03004118 Phase 4 ACTIVE_NOT_RECRUITING

The investigators aim to evaluate ursochol as a therapy in functional dyspepsia. The objectives of the study are to evaluate the effect of ursochol on duodenal permeability and dyspeptic symptoms and on duodenal low-grade inflammation, bile acid composition, bile acid receptor expression, nutrient tolerance and intragastric pressure. Cross-over, controlled, randomized, double blinded, placebo-controlled trial with a 4 week intake of ursodeoxycholic acid (ursochol) versus a 4 week intake of placebo and a 4 week washout period in between. Two study days are planned during week 4 and week 12. During the 14 weeks, the patients have to fill in a diary. And for 14 weeks in total, the patients have to discontinue intake of proton pump inhibitors, drugs effecting gastric motility and NSAIDs and replace their oral anticonception with non-oral anticonception. Every two weeks of the study the investigator will call the participants to see how they are/if they have any discomforts or side effects.

Details

Lead sponsorUniversitaire Ziekenhuizen KU Leuven
PhasePhase 4
StatusACTIVE_NOT_RECRUITING
Enrolment16
Start date2017-01
Completion2025-11

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