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.
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
- Type of treatment
- Medical device, Surgery or procedure
- 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.
- Conditions
- Functional Dyspepsia
- 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 group | Role | What they receive |
|---|---|---|
| Duodenal fluid aspiration | Other | Not 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.
Duodenal mucosal transepithelial electrical resistance (Ohm*cm^2)
Measurement for mucosal integrity
Measured: 2 hours
Duodenal paracellular passage of Fitc Dextran 4 kDa (pmol)
Measurement for mucosal integrity
Measured: 2 hours
Glycocholic acid concentration (mM)
Bile salt
Measured: 2.5 hours
Taurocholic acid concentration (mM)
Bile salt
Measured: 2.5 hours
Glycochenodeoxycholic acid concentration (mM)
Bile salt
Measured: 2.5 hours
Taurochenodeoxycholic acid concentration (mM)
Bile salt
Measured: 2.5 hours
Glycodeoxycholic acid concentration (mM)
Bile salt
Measured: 2.5 hours
Taurodeoxycholic acid concentration (mM)
Bile salt
Measured: 2.5 hours
Glycoursodeoxycholic acid concentration (mM)
Bile salt
Measured: 2.5 hours
Tauroursodeoxycholic acid concentration (mM)
Bile salt
Measured: 2.5 hours
Secondary outcomes (19)
Duodenal mucosal mastcell count (number of mastcells/mm^2 lamina propria)
Measured: 2 years
Duodenal mucosal eosinophil count (number of eosinophils/mm^2 lamina propria)
Measured: 2 years
RNA expression of Vitamin D receptor (VDR)
Real-time RT-PCR
Measured: 2 years
RNA expression of bile acid receptor FXR
Real-time RT-PCR
Measured: 2 years
RNA expression of bile acid receptor PXR
Real-time RT-PCR
Measured: 2 years
RNA expression of bile acid receptor TGR5
Real-time RT-PCR
Measured: 2 years
RNA expression of bile acid receptor CAR
Real-time RT-PCR
Measured: 2 years
Protein expression of bile acid receptor VDR
Western blot
Measured: 2 years
Protein expression of bile acid receptor FXR
Western blot
Measured: 2 years
Protein expression of bile acid receptor PXR
Western blot
Measured: 2 years
Protein expression of bile acid receptor TGR5
Western blot
Measured: 2 years
Protein expression of bile acid receptor CAR
Western blot
Measured: 2 years
Stomach complaints questionnaire
Questions about stomach complaints
Measured: 2 years
ReQuest Questionnaire
Reflux evaluation
Measured: 2 years
Council of Nutrition appetite questionnaire
Questions about appetite
Measured: 2 years
Bowel complaints questionnaire
Questions about bowel complaints
Measured: 2 years
Patient health questionnaire
Questions about health
Measured: 2 years
Anxiety sensitivity index
Questions about anxiety sensitivity
Measured: 2 years
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.
- First posted26 Dec 2016 (estimated)
- Study startMar 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Luminal Bile Salt Content and Duodenal Mucosal Integrity in Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT03003234
- Acronym / sponsor ID
- Bile acid-permeability
- Conditions
- Functional Dyspepsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 26 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duodenal fluid aspiration | Other | Procedure: Duodenogastroscopy, Device: Duodenal aspiration catheter, Dietary Supplement: Nutri drink |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- FD patients have to fulfill the Rome III criteria for functional dyspepsia.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuodenogastroscopyCatheter goes through the mouth in the duodenum to take duodenal biopsies. | Procedure or surgery | Duodenal fluid aspiration |
| Duodenal aspiration catheterCatheter goes through the nose in the duodenum to aspirate duodenal fluid in fasted and fed state. | Device | Duodenal fluid aspiration |
| Nutri drinkLiquid meal of 200 ml. | Dietary supplement | Duodenal fluid aspiration |
Primary outcome
Duodenal mucosal transepithelial electrical resistance (Ohm*cm^2)
Time frame: 2 hours
Measurement for mucosal integrity
Duodenal paracellular passage of Fitc Dextran 4 kDa (pmol)
Time frame: 2 hours
Measurement for mucosal integrity
Glycocholic acid concentration (mM)
Time frame: 2.5 hours
Bile salt
Taurocholic acid concentration (mM)
Time frame: 2.5 hours
Bile salt
Glycochenodeoxycholic acid concentration (mM)
Time frame: 2.5 hours
Bile salt
Taurochenodeoxycholic acid concentration (mM)
Time frame: 2.5 hours
Bile salt
Glycodeoxycholic acid concentration (mM)
Time frame: 2.5 hours
Bile salt
Taurodeoxycholic acid concentration (mM)
Time frame: 2.5 hours
Bile salt
Glycoursodeoxycholic acid concentration (mM)
Time frame: 2.5 hours
Bile salt
Tauroursodeoxycholic acid concentration (mM)
Time frame: 2.5 hours
Bile salt
19 secondary outcomes
Duodenal mucosal mastcell count (number of mastcells/mm^2 lamina propria)
Time frame: 2 years
Duodenal mucosal eosinophil count (number of eosinophils/mm^2 lamina propria)
Time frame: 2 years
RNA expression of Vitamin D receptor (VDR)
Time frame: 2 years
RNA expression of bile acid receptor FXR
Time frame: 2 years
RNA expression of bile acid receptor PXR
Time frame: 2 years
RNA expression of bile acid receptor TGR5
Time frame: 2 years
RNA expression of bile acid receptor CAR
Time frame: 2 years
Protein expression of bile acid receptor VDR
Time frame: 2 years
Protein expression of bile acid receptor FXR
Time frame: 2 years
Protein expression of bile acid receptor PXR
Time frame: 2 years
Protein expression of bile acid receptor TGR5
Time frame: 2 years
Protein expression of bile acid receptor CAR
Time frame: 2 years
Stomach complaints questionnaire
Time frame: 2 years
ReQuest Questionnaire
Time frame: 2 years
Council of Nutrition appetite questionnaire
Time frame: 2 years
Bowel complaints questionnaire
Time frame: 2 years
Patient health questionnaire
Time frame: 2 years
Anxiety sensitivity index
Time frame: 2 years
Visceral sensitivity index
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.