Therapeutic Effect of Ursodeoxycholic Acid in Functional Dyspepsia

NCT03004118 | Active Not Recruiting Phase 4

• 1 other identifier: UDC1
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (4)

• Duodenal mucosal transepithelial electrical resistance (TEER) (Ohm*cm^2) measured with adapted ussing chamber system

  Transepithelial resistance is a measure for mucosal integrity

  2 hours

• Duodenal mucosal paracellular passage of Fitc Dextran 4kDa (pmol) measured with FLUOstar Omega microplate reader.

  Paracellular permeability is a measure for mucosal integrity

  2 hours

• Dyspeptic symptom occurence and intensity during meal intake via questionnaire every 1 minute until end of the meal

  Scoring of dyspeptic symptom occurence by patients during nutrientdrink perfusion

  About 10 minutes

• Daily occurence and intensity of dyspeptic symptoms via LPDS diary

  Leuven Postprandial Distress Scale, a questionnaire for symptom assessment in the functional dyspepsia/postprandial distress syndrome.

  14 weeks

Secondary Outcomes (21)

• Glycocholic acid concentration (mM)

  14 weeks

• Taurocholic acid concentration (mM)

  14 weeks

• Glycochenodeoxycholic acid concentration (mM)

  14 weeks

• Taurochenodeoxycholic acid concentration (mM)

  14 weeks

• Glycodeoxycholic acid concentration (mM)

  14 weeks

Study Arms (2)

Ursochol

ACTIVE COMPARATOR

About 10.5mg/kg/day of ursochol (calculated before start study for each participant individually) (combination of ursochol 150 and 300) divided in 2 doses per day (during lunch and dinner). Oral intake. Tablets. 4 weeks.

Dietary Supplement: Nutridrink; Device: High resolution manometry probe; Device: perfusion catheter; Drug: Ursochol oral tablet; Device: Duodenal fluid aspiration catheter; Procedure: Duodenogastroscopy; Procedure: Blood sample

Placebo

PLACEBO COMPARATOR

Same amount of pills as ursochol (calculated before start study for each participant individually) divided in 2 doses per day (during lunch and dinner). Oral intake. Tablets. 4 weeks.

Dietary Supplement: Nutridrink; Device: High resolution manometry probe; Device: perfusion catheter; Drug: Placebo Oral Tablet; Device: Duodenal fluid aspiration catheter; Procedure: Duodenogastroscopy; Procedure: Blood sample

Interventions

Nutridrink DIETARY_SUPPLEMENT

Liquid meal of 200ml

Placebo; Ursochol

High resolution manometry probe DEVICE

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

Placebo; Ursochol

perfusion catheter DEVICE

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

Placebo; Ursochol

Placebo Oral Tablet DRUG

4 week oral intake (daily)

Placebo

Ursochol oral tablet DRUG

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

Ursochol

Duodenal fluid aspiration catheter DEVICE

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

Placebo; Ursochol

Duodenogastroscopy PROCEDURE

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

Placebo; Ursochol

Blood sample PROCEDURE

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

Placebo; Ursochol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women (age 18-60 years) who meet the Rome IV criteria for functional dyspepsia can participate in the study. For 14 weeks, patients need to discontinue their intake of proton pump inhibitors, drugs effecting gastric motility and NSAIDs. If a female participant takes oral anticonception, she has to switch to non-oral anticonception for this study. All participants will receive and sign a copy of the informed consent.

You may not qualify if:

• refused informed consent
• pregnant women or women who are breastfeeding
• diabetes mellitus
• celiac disease
• coagulation disorders/anticoagulant therapy
• not well functioning liver and gallbladder
• active stomach or gut ulcer
• biliary colic, calcified gallstones
• acute infection of gallbladder or bile ducts, bile duct obstruction
• intestinal disorders such as ulcerative colitis, Crohn's disease
• lactose intolerance
• allergies/sensitivity (asthma, allergic to bile acids, eczema, allergic rhinoconjunctivitis)
• Intake of oral anticonception, barbiturates, antacid, colestyramine or colestipol, nitrendipine, cyclosporine, ciprofloxacine, rosuvastatine.
• first degree relatives with celiac disease, Crohn's disease or type I diabetes mellitus Severe kidney malfunction

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Interventions

Ursodeoxycholic Acid; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 28, 2016
• Study Start: January 1, 2017
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share