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Association Between Luminal Bile Salt Content and Duodenal Mucosal Integrity in Functional Dyspepsia

NCT03003234 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-12-26

No results posted yet for this study

Summary

Functional dyspepsia (FD) is an extremely common disorder of gastrointestinal function. Recently, impaired duodenal mucosal integrity was reported as a potential pathophysiological mechanism in FD. However, the factors controlling duodenal mucosal integrity remain unknown. In this study, we evaluated whether the luminal bile salt content could play a role in impaired duodenal permeability in FD.

Duodenal biopsies were obtained from 25 healthy volunteers (HV) and 25 FD patients. Biopsies were mounted in Ussing chambers to measure transepithelial resistance (TEER) and paracellular permeability using fluorescein isothiocyanate dextran (FITC-dx4, MW 4kDa). Expression of bile acid-sensing receptors (TGR5, VDR, PXR, FXR and CAR) in duodenal biopsies was measured by western blot and real time RT-PCR. Immunohistochemistry was used to evaluate eosinophil and mastcell infiltration in duodenal biopsies of FD patients and HV. Duodenal fluid aspirates were collected at fixed time points during 1 hour in fasted state and 1.5 hours after a liquid meal (Nutridrink, 200ml). Concentration and composition of the bile salt pool (including glycocholic acid (GC), taurocholic acid (TC), glycochenodeoxycholic acid (GCDC), taurochenodeoxycholic acid (TCDC), glycodeoxycholic acid (GDC), taurodeoxycholic acid (TDC), glycoursodeoxycholic acid (GUDC) and tauroursodeoxycholic acid (TUDC)) in these aspirates was evaluated by liquid chromatography-mass spectrometry-selected ion monitoring analysis (LC-MS/MS).

Conditions

  • Functional Dyspepsia

Interventions

PROCEDURE

Duodenogastroscopy

Catheter goes through the mouth in the duodenum to take duodenal biopsies.

DEVICE

Duodenal aspiration catheter

Catheter goes through the nose in the duodenum to aspirate duodenal fluid in fasted and fed state.

DIETARY_SUPPLEMENT

Nutri drink

Liquid meal of 200 ml.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-11-30
Completion
2016-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03003234 on ClinicalTrials.gov