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Functional DyspepsiaNCT03003234

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

A study testing Duodenogastroscopy, Duodenal aspiration catheter and Nutri drink in people with Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Functional Dyspepsia
What is being tested?
Duodenogastroscopy, Duodenal aspiration catheter and Nutri drink
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Mar 2015to Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • FD patients have to fulfill the Rome III criteria for functional dyspepsia.

Who cannot join

  • Symptoms or history of gastrointestinal disease (for healthy volunteers)
  • First degree relatives with celiac disease
  • Diabetes mellitus
  • Allergy/atopy (eczema, asthma, allergic rhinoconjunctivitis)
  • Coagulation disorders/anticoagulant therapy
  • First degree relatives with Crohn's disease or type I diabetes mellitus
  • Intake of antihistamines, ketotifen, cromoglycate, acetylsalicylates, NSAIDs, anticholinergics, theophylline, β2-agonists, codeine or opioid derivatives for at least 2 weeks prior to the study.
  • Steroid or immunosuppressive drug intake any time in the last 6 months

About this study

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).

Read the detailed description

The Rome III criteria defined functional dyspepsia (FD) as the presence of symptoms thought to originate in the gastroduodenal region, in the absence of any organic, systemic or metabolic disease that readily explains the complaints. FD is extremely common, affecting up to 15-20% of the population and is associated with significantly decreased quality of life and substantial healthcare costs. The available treatment options for FD are of limited effectiveness, which reflects the poorly understood pathogenesis. Studies indicate that FD is a heterogeneous disorder, in which different pathophysiological mechanisms underlie specific symptom patterns. Traditionally, gastric abnormalities such as impaired accommodation, delayed emptying and hypersensitivity have been believed to be involved in the pathophysiology of FD. More recent studies have suggested that also a number of duodenal abnormalities can be responsible for the generation of symptoms, like increased sensitivity to duodenal acid, increased sensitivity to duodenal lipids and low-grade mucosal inflammation.

The investigators recently showed that FD patients display impaired duodenal mucosal integrity. The trigger of increased permeability is unknown, but it is possible that increased exposure to duodenal bile acids or an altered composition of bile acids leads to impairment of the intestinal barrier. This sustained enhancement of paracellular permeability could facilitate the constant passage of luminal antigens through the mucosa and lead to local mucosal immune responses that manifest as inflammation and finally result in generation of dyspeptic symptoms.

The investigators hypothesized that increased duodenal bile acid exposure or a change in the composition of bile acids lead to impaired duodenal mucosal integrity in FD, allowing luminal substances to pass through the mucosa and result in immune responses and finally in dyspeptic symptom generation. The general aim of this project is to assess if FD patients display increased endogenous duodenal bile acid exposure and a different bile acid composition. In addition, it will be tested whether duodenal mucosal permeability of FD patients with an endogenous duodenal bile acid exposure above the normal range and an altered bile acid composition is higher than in FD patients with a normal endogenous duodenal acid exposure and composition.

Participants will be expected on the department endoscopy of the UZ Gasthuisberg after they have fasted overnight. Before the study, they are asked to fill in a bundle of questionnaires concerning physical complaints, depression, anxiety (disturbances), pain/disease, body/interoceptive awareness, trauma/abuse and personality.

Gastroduodenoscopy will be performed by an experienced endoscopist (Jan Tack). Hereby, 12 duodenal biopsies (2 biopsies at a time) (Radial Jaw™3 with needle; outside diameter 2.2mm; Boston Scientific, 302 Parkway, Global Park, Heredia, Costa Rica) will be obtained. To measure the in vitro transepithelial resistance, 4 biopsies will be examined using an adapted mini-Ussing chambers system. After equilibration, the mucosal side of the tissue will be exposed to 4kDa FITC-dextran as a measure of paracellular permeability. A sample will be taken from the serosal side during 2h at 30min interval. The concentration of fluorescein will then be measured using a fluorescence plate reader. Also, 2 biopsies will be used for mRNA extraction and subsequent cDNA synthesis. This cDNA will be used to measure the gene expression of cell-to-cell adhesion proteins and acid-sensing receptors by means of real-time PCR. In addition, 2 biopsies will be prepared for immunofluorescence and immunohistochemistry and 2 will be used for western blot to measure changes in distribution/expression of the cell-to-cell adhesion proteins and of bile acid-sensitive receptors. Two biopsies will be obtained to study ultrastructural alterations by transmission electron microscopy.

After recovery, a catheter will be introduced in the second duodenum via the nose and the position of the catheter will be checked fluoroscopically. This catheter allows collection of intestinal fluids by means of a syringe to collect duodenal fluid aspirates and characterization of the bile acid composition of those samples (8). After 30 minutes, the participants will be given a specified amount of water (250 mL) (fasted state) and another 30 minutes later a nutritional drink (fed state). Intestinal fluids will be sampled every 15 min for a period of 1 h before the liquid meal intake and until 90 minutes after the liquid meal intake. So, after the total collection period, 7 fractions for the fed state and 4 fractions for the fasted state will be obtained per participant in a time frame of 2 hours and a half. The composition of bile acids of the intestinal samples will be determined by GC-MS-selected ion monitoring analysis.

Being tested
Duodenogastroscopy, Duodenal aspiration catheter, Nutri drink

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DuodenogastroscopyProcedure or surgery

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

  • Duodenal aspiration catheterDevice

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

  • Nutri drinkDietary supplement

    Liquid meal of 200 ml.

Study groups in NCT03003234
Study groupRoleWhat they receive
Duodenal fluid aspirationOtherNot described
Receives: Procedure: Duodenogastroscopy; Device: Duodenal aspiration catheter; Dietary Supplement: Nutri drink

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duodenal mucosal transepithelial electrical resistance (Ohm*cm^2)

    Measurement for mucosal integrity

    Measured: 2 hours

  2. Duodenal paracellular passage of Fitc Dextran 4 kDa (pmol)

    Measurement for mucosal integrity

    Measured: 2 hours

  3. Glycocholic acid concentration (mM)

    Bile salt

    Measured: 2.5 hours

  4. Taurocholic acid concentration (mM)

    Bile salt

    Measured: 2.5 hours

  5. Glycochenodeoxycholic acid concentration (mM)

    Bile salt

    Measured: 2.5 hours

  6. Taurochenodeoxycholic acid concentration (mM)

    Bile salt

    Measured: 2.5 hours

  7. Glycodeoxycholic acid concentration (mM)

    Bile salt

    Measured: 2.5 hours

  8. Taurodeoxycholic acid concentration (mM)

    Bile salt

    Measured: 2.5 hours

  9. Glycoursodeoxycholic acid concentration (mM)

    Bile salt

    Measured: 2.5 hours

  10. Tauroursodeoxycholic acid concentration (mM)

    Bile salt

    Measured: 2.5 hours

Secondary outcomes (19)
  1. Duodenal mucosal mastcell count (number of mastcells/mm^2 lamina propria)

    Measured: 2 years

  2. Duodenal mucosal eosinophil count (number of eosinophils/mm^2 lamina propria)

    Measured: 2 years

  3. RNA expression of Vitamin D receptor (VDR)

    Real-time RT-PCR

    Measured: 2 years

  4. RNA expression of bile acid receptor FXR

    Real-time RT-PCR

    Measured: 2 years

  5. RNA expression of bile acid receptor PXR

    Real-time RT-PCR

    Measured: 2 years

  6. RNA expression of bile acid receptor TGR5

    Real-time RT-PCR

    Measured: 2 years

  7. RNA expression of bile acid receptor CAR

    Real-time RT-PCR

    Measured: 2 years

  8. Protein expression of bile acid receptor VDR

    Western blot

    Measured: 2 years

  9. Protein expression of bile acid receptor FXR

    Western blot

    Measured: 2 years

  10. Protein expression of bile acid receptor PXR

    Western blot

    Measured: 2 years

  11. Protein expression of bile acid receptor TGR5

    Western blot

    Measured: 2 years

  12. Protein expression of bile acid receptor CAR

    Western blot

    Measured: 2 years

  13. Stomach complaints questionnaire

    Questions about stomach complaints

    Measured: 2 years

  14. ReQuest Questionnaire

    Reflux evaluation

    Measured: 2 years

  15. Council of Nutrition appetite questionnaire

    Questions about appetite

    Measured: 2 years

  16. Bowel complaints questionnaire

    Questions about bowel complaints

    Measured: 2 years

  17. Patient health questionnaire

    Questions about health

    Measured: 2 years

  18. Anxiety sensitivity index

    Questions about anxiety sensitivity

    Measured: 2 years

  19. Visceral sensitivity index

    Questions about visceral sensitivity

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2016 (estimated)
  2. Study startMar 2015
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03003234
Sponsor's protocol ID
Bile acid-permeability
Status last verified
Nov 2016
First submitted
5 Dec 2016
Last updated
26 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Duodenogastroscopy, Duodenal aspiration catheter and Nutri drink in people with Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duodenal mucosal transepithelial electrical resistance (Ohm*cm^2) (time frame: 2 hours). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2016.

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