Therapeutic Effect of Ursodeoxycholic Acid in Functional Dyspepsia

Summary

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.

Conditions

• Functional Dyspepsia

Interventions

DIETARY_SUPPLEMENT

Nutridrink

Liquid meal of 200ml

DEVICE

High resolution manometry probe

Catheter inserted via the nose into the stomach to measure intragastric pressure.

DEVICE

perfusion catheter

Catheter inserted via the nose into the stomach to perfuse the nutridrink intragastricly.

DRUG

Placebo Oral Tablet

4 week oral intake (daily)

DRUG

Ursochol oral tablet

4 week oral intake (daily) (dose of 10.5mg/kg/day)

DEVICE

Duodenal fluid aspiration catheter

Catheter inserted via the nose into the duodenum to aspirate duodenal fluids for 2.5 hours.

PROCEDURE

Duodenogastroscopy

Catheter inserted via the mounth into the duodenum to take duodenal biopsies.

PROCEDURE

Blood sample

Blood sample will be taken to measure liver enzyme serum levels and marker for bile acid synthesis.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2025-11-30

Completion

2025-11-30