Therapeutic effects of ursodeoxycholic acid in patients with functional dyspepsia

Phase 1

• Conditions: Functional dyspepsia (FD); Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2016-003631-37-BE
• Lead Sponsor: niversitaire ziekenhuis Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-06
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of UDC on duodenal permeability and meal related sensory motor function in patients with functional dyspepsia;Secondary Objective: To assess the effect of UDC on bile acid (BA) concentration/composition, BA receptor expression, duodenal low-grade inflammation, nutrient tolerance and dyspeptic symptom occurence;Primary end point(s): Duodenal permeability and meal related sensory motor function;Timepoint(s) of evaluation of this end point: Trial lasts for 12 weeks: all end points are measured during week 4 and week 12. <br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): duodenal luminal bile salt conposition/concentration<br>duodenal low-grade inflammation<br>nutrient tolerance<br>dyspeptic symptom onset<br>BA receptor expression;Timepoint(s) of evaluation of this end point: Trial lasts for 12 weeks: all end points are measured during week 4 and week 12.